Migraine Sufferers Rank Triptans as Most Helpful Medication

By Pat Anson, PNN Editor

A large new study that compared the effectiveness of acute migraine medications found that triptans are two to five times more helpful than ibuprofen and acetaminophen in treating migraine attacks. Triptans were also found to be more effective than Excedrin migraine, opioids, and other non-steroidal anti-inflammatory drugs (NSAIDs).

The study used a unique methodology, gathering data on over 3 million migraine attacks reported by over 278,000 people in the US, UK and Canada who used a smartphone app during a six-year period. The Migraine Buddy app allows users to monitor the frequency of their migraine attacks, triggers and symptoms, and rate how “helpful” or “not helpful” their medications are.

“There are many treatment options available to those with migraine. However, there is a lack of head-to-head comparisons of the effectiveness of these treatment options,” said lead author Chia-Chun Chiang, MD, a neurologist who specializes in Headache Medicine and Vascular Neurology at the Mayo Clinic. “These results confirm that triptans should be considered earlier for treating migraine, rather than reserving their use for severe attacks.”

Chiang and his colleagues looked at a total of 25 medications among seven drug classes. Different dosages and medication combinations were combined in their analysis. Newer drugs that inhibit calcitonin gene-related peptides (CGRP) were excluded because they were not in wide enough use during the study period.

How Patients Rated Effectiveness of Acute Migraine Drugs

NEUROLOGY

The study findings, published in the journal Neurology, ranked several triptans (eletriptan, zolmitriptan, sumatriptan, rizatriptan, naratriptan, almotriptan and frovatriptan) as the most helpful medications, with about 75% effectiveness.

By comparison, acetaminophen (paracetamol) was helpful only 37% of the time.

“Our results strongly support the use of triptans, the first class of migraine-specific medication for the acute treatment of migraine,” researchers reported. “In practice, NSAIDs and acetaminophen are generally the first-line medications utilized for mild to moderate headache, and migraine-specific medications are often reserved for moderate to severe migraine attacks, which could potentially result in under-utilization of triptans or delayed treatment during migraine attacks.”

Participants found NSAID’s more effective than acetaminophen, with ketorolac helpful 62% of the time, indomethacin helpful 57% of the time, diclofenac helpful 56% of the time and ibuprofen helpful 42% of the time.

Excedrin migraine was effective only about half the time, about the same as tramadol and codeine. Opioids are usually not recommended for migraine because they’ve been associated with medication overuse headache.

“For people whose acute migraine medication is not working for them, our hope is that this study shows that there are many alternatives that work for migraine, and we encourage people to talk with their doctors about how to treat this painful and debilitating condition,” said Chiang.

Migraine affects about 39 million people in the United States and is the second leading cause of disability worldwide, according to the American Migraine Foundation.  

Another recent study that compared migraine prevention drugs found that two medications usually used to treat depression and high cholesterol are just as effective as the new CGRP inhibitors. Amitriptyline is a tricyclic antidepressant, while simvastatin is a statin. Both drugs are used off-label for migraine prevention and cost substantially less than CGRP drugs.

Kolodny: NSAIDs ‘Just as Effective As Opioids’

By Pat Anson, PNN Editor

It’s fair to say that Dr. Andrew Kolodny is recognized as an expert in substance abuse. Koldony is board-certified in Psychiatry and Addiction Medicine, and for a few years was the Chief Medical Officer of Phoenix House, which operates a chain of addiction treatment centers. He now co-directs an opioid research program at Brandeis University.

Kolodny is also the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), has testified as a well-paid expert witness in opioid litigation, and is frequently quoted in the media about opioid painkillers, often calling them “heroin pills.”

But Kolodny is not board-certified in pain management and is not recognized as an “expert” in treating physical pain. So it was a bit of a surprise to hear him giving medical advice about over-the-counter pain relievers last week in a webinar held by the Partnership for a Drug-Free New Jersey.

"Many people don't know this, but the class of analgesic known as NSAIDs are as effective and in some cases more effective than opioids, even for excruciating painful conditions like renal colic. It's also called kidney stone pain. NSAIDs have been shown to be just as effective,” Kolodny said.  

Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen are widely used to treat minor pain and headaches, but they are not generally used for severe or chronic pain.  

We asked Mary Maston what she thought about Kolodny’s advice. She is an expert on kidney stone pain, having been born with a congenital disorder called medullary sponge kidney (MSK), which causes her kidneys to continually produce new stones.  

“The class of analgesic known as NSAIDs are as effective and in some cases more effective than opioids, even for excruciating painful conditions.”

— Dr. Andrew Kolodny

“I wholeheartedly disagree that NSAIDs are as effective and in some cases more effective than opioids,” Maston told us. “My first thought was, ‘I wonder if he's ever had a kidney stone?’ Ask any patient that has, whether they have MSK like me or not, and they will quickly tell you that over-the-counter NSAIDs do absolutely nothing for kidney stone pain. I have never encountered a single patient that has said they just took some Aleve and that took care of the pain even a little bit.” 

Kolodny was just getting started. He also recommended acetaminophen (Tylenol) as an alternative to opioids, and said it can be combined with ibuprofen (Advil) for even stronger pain relief. 

“Tylenol is not as strong a pain reliever as NSAIDs, but can for some people be very effective. And fortunately, you can actually combine a drug like Advil with a drug like Tylenol because they work differently. As long as a patient is able to take Tylenol and is able to take Advil, as long as they don't have a contradiction to taking those medications, they can even be combined,” Kolodny said. 

“The combination of Tylenol and Advil is actually first-line for wisdom tooth removal, even though in many cases dentists often still give drugs like hydrocodone or oxycodone to teenagers when their wisdom teeth come out. Tylenol and Advil combined gives better pain relief, with less side effects." 

“What he said about kidney stones is not correct. In fact, it’s cruel. What he said about tooth extractions is correct,” says Jeffrey Fudin, PharmD, an expert in pharmacology and pain management. “But encouraging expanded chronic NSAID use without preliminary discussion with a physician or pharmacist is bad and he is oversimplifying. Pain source, cause, quality and quantity all need to be assessed. 

“And he didn’t offer what should be done for those patients that can’t take NSAIDs due to medical disorders or who can’t tolerate them or they don’t work. What do we do, not treat them?” 

Risky Side Effects of OTC Drugs

NSAIDs and acetaminophen are widely used over-the-counter pain relievers, and both can have serious side effects. NSAIDs increase the risk of heart attacks and stroke, while excessive use of acetaminophen can cause liver, kidney, heart and blood pressure problems. A recent study found little or no evidence to support the use acetaminophen for most pain conditions.  

Kolodny, who does not speak with this reporter, briefly acknowledged some of those issues during the webinar. 

“Some patients have medical problems where they are not able to take an NSAID. And sometimes for severe acute pain there is a role for opioids. But that should always be very short-term use. Or if it's ever prescribed for a chronic pain condition, intermittent use, meaning not taken every day. Because when opioids are taken every day, quickly patients develop tolerance to the pain-relieving effect,” Kolodny said. 

“He makes it sound as though it’s either opioids or NSAIDS/acetaminophen,” Fudin said in an email to PNN. “There are lots of options that can be used instead of opioids or in addition to opioids other than NSAIDs/acetaminophen in an effort to combine multiple different pharmacological mechanisms permitting lower doses of several drugs.”

An over-the-counter pain reliever that combines ibuprofen and acetaminophen was recently introduced called Advil Dual Action, but it is marketed as a treatment for “minor aches and pains” such as headaches, toothaches and menstrual cramps. Nothing about severe pain, chronic pain or kidney stones.

“NSAIDs have been known to cause acute kidney failure in patients that have perfectly healthy kidneys, and my nephrologist says we don't want to tempt the gods,” says Mary Maston. “Once I explain this to ER doctors and anesthesiologists when I have surgery, they quickly nod and agree.”

Maston would like to see an end to one-size-fits-all approaches to pain care and for providers to treat patients as individuals. One way to do that is with CYP450 testing, which looks for enzymes that determine how effective a medication will be in a patient.

“I personally think it's time to stop cramming all patients into convenient little boxes and start making CYP450 tests mandatory for anyone who suffers with chronic conditions. It would take the guesswork out of prescribing, prevent patient suffering, and eliminate the stigma, abuse and neglect of chronic pain patients by their providers,” she said. 

Dr. Fudin would like to see Dr. Kolodny stay in his lane as a psychiatrist and addiction treatment doctor. 

“Would it be okay for a board-certified pain specialist professing to be an expert and to opine under those circumstances on best drugs for schizophrenia?” asked Fudin.

Study Debunks Warning About Taking NSAIDs for COVID-19

By Pat Anson, PNN Editor

We’ve learned a lot about COVID-19 over the last few months, including what medications help and don’t help coronavirus patients. While much attention has been focused on the antiviral drugs hydroxychloroquine and remdesivir, other more common medications used to treat pain and inflammation have been found to be useful in treating COVID-19 infections.

In the early stages of the pandemic, some health experts warned that non-steroidal anti-inflammatory drugs (NSAIDs) – ibuprofen in particular – could weaken the immune system and make coronavirus symptoms worse. The French government even warned of "grave adverse effects" linked to the use of NSAIDs by COVID-19 patients and recommended acetaminophen (paracetamol) as a safer alternative.

“Taking anti-inflammatory drugs (ibuprofen, cortisone, ...) could be an aggravating factor of the infection. If you have a fever, take paracetamol,” tweeted Dr. Olivier Véran, France’s Health Minister.

That claim has now been debunked by Danish researchers, who reported in PLOS Medicine that ibuprofen and other NSAIDs do not increase the risk of serious illness from coronavirus infections. The researchers reached their conclusion after analyzing the health data of over 9,300 Danish residents who tested positive for the SARS-CoV-2 virus between February 27 and April 29, 2020.

In Denmark, NSAIDs are sold by prescription, except for low-dose ibuprofen that is sold over-the-counter. Researchers identified 248 coronavirus patients who filled a prescription for NSAIDs within 30 days of their positive COVID-19 tests and found they had the same risk of being hospitalized and dying from the coronavirus as those who did not take NSAIDs.

“Use of NSAIDs was not associated with increased 30-day mortality, a finding that was robust in a range of supplementary analyses. Likewise, use of NSAIDs was not associated with an increased risk of hospitalization, ICU admission, mechanical ventilation, or renal replacement therapy in the adjusted analyses,” researchers reported.

“Considering the available evidence, there is no reason to withdraw well-indicated use of NSAIDs during the SARS-CoV-2 pandemic. However, the well-established adverse effects of NSAIDs, particularly their renal, gastrointestinal, and cardiovascular effects, should always be considered, and NSAIDs should be used in the lowest possible dose for the shortest possible duration for all patients.”

Concerns about steroid drugs resulting in poor outcomes for coronavirus patients are also misplaced, according to an analysis of studies recently published in JAMA. Researchers found that corticosteroids can actually be lifesaving for coronavirus patients and should be the first-line treatment for critically ill patients.

Two other recent studies found that patients with lupus and other forms of arthritis are not at increased risk of serious illness from COVID-19 due to the medications they take. Arthritis is often treated with steroids, biologics and other immune suppressing medications, which had raised concern that the drugs could make patients more susceptible to coronavirus infections. But researchers found that patients with arthritis in the New York City area had the same risk of hospitalization as the general population during the height of the city’s pandemic.

Confusion Over Ibuprofen as Coronavirus Treatment

By Pat Anson, PNN Editor

With the number of coronavirus cases growing to nearly 200,000 worldwide, so is confusion about which over-the-counter pain reliever should be used to treat its symptoms. Some health experts say acetaminophen – known as paracetamol outside the U.S. – is better than ibuprofen, aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

"We recommend paracetamol, not ibuprofen for self-medicating," Christian Lindmeier, a spokesman for the World Health Organization said today.

At issue is whether ibuprofen and other NSAIDs interfere with the body’s immune system and make coronavirus symptoms worse. The debate was kicked off Saturday by a tweet from France’s Health Minister.

“Taking anti-inflammatory drugs (ibuprofen, cortisone, ...) could be an aggravating factor of the infection. If you have a fever, take paracetamol,” said Dr. Olivier Véran, a neurologist.

That same day, the French government reported "grave adverse effects" linked to the use of NSAIDs in coronavirus patients and released new guidelines saying “the treatment of a fever or of pain linked to COVID-19 or to any other respiratory viral disease should be paracetamol.”

But the UK’s Royal Pharmaceutical Society (RPS) disputed whether there was enough evidence to make such a recommendation.

“There is not currently enough information on ibuprofen use and COVID-19 to advise people to stop using NSAIDs. There is currently no published scientific evidence that ibuprofen increases the risk of catching COVID-19 or makes the illness worse. In addition, there is also no conclusive evidence that taking ibuprofen is harmful for other respiratory infections,” the RPS said in a statement.

The Medical University of Vienna also chimed in, calling reports that it had found a connection between ibuprofen use and worse coronavirus symptoms "fake news."

But other experts agreed that NSAIDs can weaken the immune system.

“Despite all of their beneficial effects, it has long been known that anti-inflammatories can have a depressive effect on parts of our immune systems,” Dr. Amir Khan of Britain’s National Health Service said in Al Jazeera. “If we take medicines that dampen this immune response, such as ibuprofen, this can lead to us not fighting off the infection as effectively, potentially leading to a longer illness with a higher risk of complications.

“Paracetamol is not an anti-inflammatory medication and can be used to effectively treat fever as well as mild to moderate pain and can, therefore, be used safely to help treat the fever associated with the coronavirus.”

The NHS also updated its recommendations, cautioning that while there is no strong evidence that ibuprofen makes coronavirus worse, “until we have more information, take paracetamol to treat the symptoms of coronavirus.”

‘Don’t Give Her Ibuprofen!’

The New York Post reported that a 4-year old British girl suffering coronavirus symptoms had difficulty breathing and took a turn for the worse after taking ibuprofen. Amelia Collins had a cough, fever and other flu-like symptoms.

“To those of you that have children please read. If your child has symptoms of corona virus, DO NOT give them ibuprofen,” Amelia’s father posted on Facebook. “Within an hour of giving her [ibuprofen] she dropped dramatically. She was panting while trying to breathe, her heart rate was very rapid, she couldn’t keep her eyes open, couldn’t lift her head up, her body was shaking, she started being sick on herself and her temperature had risen.”

Amelia’s parents called for an ambulance. Fortunately, paramedics were able reduce her fever without taking her to a hospital.

“Now she’s back on [acetaminophen] she’s back to just being her poorly self. The paramedics only told us while here that were not to give her ibuprofen!” the father said.

In 2015, the U.S. Food and Drug Administration warned that “everyone may be at risk” and ordered new warning labels for ibuprofen and other NSAIDs to indicate they increase the risk of a fatal heart attack or stroke.

But acetaminophen also has issues. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. Acetaminophen is the active ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – and many consumers have no idea how much acetaminophen they’re taking.

Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and hundreds of deaths.

Is JAMA Opioid Study Based on Junk Science?

By Pat Anson, Editor

You may have read about a research study published this week in the Journal of the American Medical Association (JAMA), which compared the effectiveness of opioid and non-opioid medications in treating chronic pain. 

The yearlong study of 240 patients found that opioids were not superior to pain relievers like acetaminophen and ibuprofen in treating chronic back pain or hip and knee pain caused by osteoarthritis.  Pain improved for 41% of the patients who took opioids, compared to 54% in the non-opioid group.  

It’s an interesting study – one of the few to look at the effectiveness of any pain relievers long term – but some critics are questioning the study’s methodology and the alleged anti-opioid bias of its lead author, Erin Krebs, MD, a researcher for the Department of Veterans Affairs.

First let’s look at some of the news coverage the study is getting.

“Opioids Don’t Treat Chronic Pain Any Better Than Ibuprofen” reads the headline in Newsweek, an article that never mentions the JAMA study was limited to patients with back pain or osteoarthritis.

“Opioids Don’t Beat Other Medications for Chronic Pain” was the headline in NPR.com, while the Chicago Tribune went with “Opioids no better than common painkillers for treating chronic pain.”

The Tribune article included a quote from one of the co-authors of the CDC opioid guidelines. "The fact that opioids did worse is really pretty astounding," said Roger Chou, MD. "It calls into question our beliefs about the benefits of opioids."

Notice the news coverage strongly suggests that opioids are ineffective for all types of chronic pain – not just back pain and osteoarthritis.  Patients living with chronic pain from arachnoiditis, trigeminal neuralgia or some other intractable pain condition would probably disagree about that. And they'd find the idea of taking ibuprofen laughable, if not infuriating. But no one asked for their opinion.

Also unmentioned is that opioids are usually not prescribed for osteoarthritis or simple back pain, which are often treated with NSAIDs and over-the-counter pain relievers.

So, what JAMA has published is a government funded study designed to look at a treatment (opioids) that most people with back pain and arthritis never actually get.

“You've been had by anti-opioid advocates disguising their advocacy as science.  Krebs is well known in professional circles for this kind of distorted advocacy junk science,” wrote patient advocate Red Lawhern, PhD, in a comment submitted to the Philadelphia Inquirer after it published a misleading headline of its own, “Prescription opioids fail rigorous new test for chronic pain.”

“I suggest that you retract your article.  In its present form, it is propaganda not fact,” said Lawhern, a co-founder of the Alliance for the Treatment of Intractable Pain (ATIP). “Opioids have never been the first-line medical treatment of choice in lower back pain or arthritis. That role is served by anti-inflammatory meds, some of them in the prescription cortico-steroid family.  NSAIDs have a role to play, recognizing that they are actively dangerous in many patients if taken at high doses for long periods.  Hundreds of people die every year of cardiac arrest or liver toxicity due to high-dose acetaminophen or ibuprofen.” 

Who is Erin Krebs?  

Dr. Krebs is an associate professor at the University of Minnesota Medical School and a prolific researcher at the VA Medical Center in Minneapolis.

She was also an original member of the “Core Expert Group” – an advisory panel that secretly drafted the CDC’s controversial opioid guidelines while getting a good deal of input from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). The guidelines recommend that opioids not be prescribed for chronic pain.

Krebs also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Some of her previous opioid research has been controversial. In a study published last year in the Annals of Internal Medicine, Krebs reviewed 67 studies on the safety and effectiveness of opioid tapering. Most of the studies were of poor quality, but nevertheless Krebs came to the conclusion that pain levels and the quality of life of patients “may improve during and after opioid dose reduction.”

ERIN KREBS, MD

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

PROP founder Andrew Kolodny, MD, read the review and liked it, tweeting that “dangerously high doses should be reduced even if patient refuses.”

But forced opioid tapering is never a good idea, according to a top CDC official.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial also published in the Annals of Internal Medicine. 

As for Krebs’ contention that there is “insufficient evidence” of adverse events associated with opioid tapering, that notion may be put to rest next month when the VA releases a new study showing that tapering has led to a growing number of suicides by veterans.

In a summary of the findings, which will be presented at the Rx Drug Abuse & Heroin Summit, VA researchers report that “opioid discontinuation was not associated with overdose mortality, but was associated with increased suicide mortality.”  

Who and what should we believe in the neverending debate about opioids? PNN columnist Roger Chriss wrote about Krebs’ opioids vs. non-opioids study last year, when the initial reports of its findings came out. Roger said prescribing decisions are best left to physicians who know their patients’ medical conditions – not researchers, regulators or the news media.

“In reality, there is no ‘versus’ here. Opioids and NSAIDs are both valuable tools for chronic pain management. To pretend that one is inherently better than the other is to miss the essential point: Both work and should be available for use as medically appropriate,” Roger wrote. 

Do OTC Pain Relievers Dull Your Emotions?

By Pat Anson, Editor

Ibuprofen, acetaminophen and other over-the-counter pain relievers may do more than just dull your physical pain. They could also dull your emotional and cognitive senses, according to a new study.

Researchers at the University of California, Santa Barbara reviewed a small body of clinical studies that suggest OTC pain medications have an overlapping effect on us, both physically and emotionally.

One study, for example, found that acetaminophen makes people feel less empathy for others.

Research also found that women who took ibuprofen reported less social anxiety and hurt feelings after being excluded from a game or when writing about a time when they felt betrayed.

Yet another study found that acetaminophen lessens the discomfort of parting with a prized possession. When asked to set a selling price on an object they owned, individuals who took acetaminophen set prices that were cheaper than the prices set by individuals who took placebos.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.

“Are more regulations needed? Should warnings be expanded on drug labels? At this point, drawing strong conclusions from the existing studies would be premature. Nonetheless, policymakers might start thinking about potential public health risks and benefits.”

Ratner and his colleagues say one place to start is to further study the effects of OTC analgesics on pregnant women. Recent research has found higher rates of autism and attention deficit disorder (ADHD) in young children whose mothers used acetaminophen while pregnant.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Ibuprofen is also widely used and can be found in brand name products such as Motrin and Advil.   

“Found in medicine cabinets across the world and used multiple times per week by people of all ages, genders, and ethnic backgrounds, these drugs are woven into modern life. Policymakers should take note of existing findings but not rush to judgment,” said Ratner.

The study is published online in the journal Policy Insights from the Behavioral and Brain Sciences.

Ibuprofen Linked to Reduced Male Fertility

By Pat Anson, Editor

If you’re a man who uses ibuprofen regularly for muscle pain or  headache, you could be compromising your ability to have children, according to a small new study.

French and Danish researchers enrolled 31 young male volunteers between the ages of 18 and 35 in the study, and gave about half of them 600 milligrams of ibuprofen twice a day -- the highest recommended dose. The other participants were given a placebo.

After just 14 days, the researchers noted signs of hormonal dysfunction in the men who took ibuprofen, who had high levels of luteinizing hormone, which the pituitary gland produces to stimulate testosterone production in the testicles. 

That condition -- known as hypogonadism -- is usually seen in older men who have low testosterone levels. Hypogonadism is associated with reduced fertility, lower sex drive, depression, fatigue and an increased risk of cardiovascular problems.

“We normally see this condition in elderly men, so it raises an alarm,” study co-author Bernard Jégou, PhD, of the French National Institute of Health and Medical Research, told The Guardian. “We are concerned about it, particularly for healthy people who don’t need to take these drugs. The risk is greater than the benefit.” 

Researchers say the disorder was mild in the ibuprofen group and went away when the men stopped taking ibuprofen. But they worry what would happen to men who take the pain reliever for longer periods. Many professional athletes regularly take high doses of ibuprofen.

“Our immediate concern is for the fertility of men who use these drugs for a long time,” said co-author David Møbjerg Kristensen, PhD, a professor of biology at the University of Copenhagen. “These compounds are good painkillers, but a certain amount of people in society use them without thinking of them as proper medicines.”

The study was published online in the Proceedings of the National Academy of Sciences .

“Ibuprofen appears to be the preferred pharmaceutical analgesic for long-term chronic pain and arthritis. Therefore it is also of concern that men with compensated hypogonadism may eventually progress to overt primary hypogonadism, which is characterized by low circulating testosterone and prevalent symptoms including reduced libido, reduced muscle mass and strength, and depressed mood and fatigue,“ the researchers warned.

The same team of researchers reported in earlier studies that aspirin, acetaminophen and ibuprofen affected the testicles of male babies born to mothers who took the drugs during pregnancy.

Ibuprofen is a widely used over-the-counter pain reliever found in brand name products such as Motrin and Advil.   

Painkiller Study Conducted at Poorly Rated Hospital

By Pat Anson, Editor

Over-the-counter pain relievers are just as effective as opioid medication in treating short-term acute pain in a hospital emergency room, according to a widely touted study published in the Journal of the American Medical Association (JAMA).

The study was relatively small – only 416 patients participated – and it was conducted at a New York City hospital with a poor history of pain care. Still, it's getting a lot of media coverage. “Milder pill may be best for pain” is the front page headline in the Los Angeles Times. “Drugstore pain pills as effective as opioids” said STAT News. “Opioids Not the Only Answer for Pain Relief” reported HealthDay.  

Researchers said patients with moderate to severe acute pain in their arms or legs got just as much pain relief after being given a combination of acetaminophen and ibuprofen than those who took hydrocodone, oxycodone or codeine. The study only measured pain relief for two hours.

Patients with sickle cell disease, fibromyalgia, neuropathy or any type of pain that lasted more than seven days were excluded from the study because researchers only wanted to focus on short term pain.

"Although this study focused on treatment while in the emergency department, if we can successfully treat acute extremity pain with a non-opioid combination painkiller in there, then we might be able to send these patients home without an opioid prescription," said lead author Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center.

"We know that some patients who are given an opioid prescription will become addicted, so if we can decrease the number of people being sent home with an opioid prescription, then we can prevent people from becoming addicted in the first place."

What Chang, JAMA and the news reports all fail to mention is that the study was conducted at one of the worst hospitals in the nation. In an annual survey of Medicare patients, Montefiore Medical Center in New York City was given only one star (out of five possible), placing it in the bottom 2.44% of hospitals nationwide.

Montefiore was rated poorly on a variety of quality measures, including pain care. Only 64 percent of the patients treated there said their pain was “always” well controlled, compared to the national average of 71 percent.

‘Worst Hospital in the Entire City’

Many of the online reviews of Montefiore’s emergency room are scathing.

“Please do not come to the ER unless you want to die or are used to unsympathetic health professionals,” warned Amanda G. on Yelp.  “I have severe abdominal pain and I'm walking home in tears right now. I came in told the nurse there my symptoms and she couldn't have made it clearer that she couldn't care less.”

“This has to be the worst hospital in the entire city. The nurses in the ER are rude and don't care about your well being. The ER is filthy. People stacked on top of each other,” wrote Robert in a Google review.

MONTEFIORE MEDICAL CENTER PHOTO

“The emergency room sucks. The doctors sit around on the computers gossiping. I even overheard a few doctors saying ‘why aren’t we picking up patients?’ Meanwhile there’s a room full of patients not being taken care of. There’s a patient screaming for help and no one hears him. All the staff members just walk by him,” wrote Zoe D. on Yelp.

“Somebody told me this place was the equivalent of going to a hospital in Manhattan. They lied! I went to the emergency room today for chest pains, I ended up sitting there for four hours never to be seen by a doctor. I ended up walking out and leaving still with my chest pains,” said Phonz R. on Yelp.

“Their ER department is horrible. I went to the ER with my mom via ambulance, we got there (a little) before 1pm. Fast forward 1:58 in the morning she still wasn't put in a room,” wrote J.L. Eaddy on Google. “This was the absolute worst ER I've ever encountered. And I NEVER want to come back again. I wish I had the option to give it negative stars.”

Unfortunately, complaints such as these are not unusual in busy, urban teaching hospitals like Montefiore.  And not all the reviews are poor. U.S. News and World Report gave high rankings to Montefiore in a number of areas, although it didn’t specifically rank its emergency department. Montefiore was recently given a lukewarm “C” rating by the Leapfrog group, a non-profit that grades hospitals on quality and safety.  

Many pain patients have poor experiences in hospitals. In a survey of nearly 1,300 patients by PNN and the International Pain Foundation, over half rated the quality of their pain care in hospitals as either poor or very poor. About two-thirds of the patients said non-opioid pain medications were ineffective.

Hydrocodone Prescriptions Continue Falling

By Pat Anson, Editor

For the fifth year in a row, fewer prescriptions for the opioid painkiller hydrocodone were dispensed in the U.S. in 2016, according to a new report by the QuintilesIMS Institute, which tracks prescription drug use and spending.

The report adds further evidence that the nation’s overdose epidemic is being fueled by illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

About 7 million fewer prescriptions were filled last year for hydrocodone, which is usually combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone combination products.

As recently as 2012, hydrocodone was the #1 most widely dispensed medication in the nation, with 136 million prescriptions filled. Since then, hydrocodone prescriptions have fallen by over a third, to 90 million prescriptions.

Hydrocodone now ranks fourth, behind the thyroid drug levothyroxine (Synthroid), the blood pressure medication lisinopril (Zestril), and the statin atorvastatin (Lipitor).

Hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, making it harder to obtain. Opioid guidelines released last year by the CDC also probably had an impact, although hydrocodone prescriptions were falling long before the CDC and DEA acted.

HYDROCODONE PRESCRIPTIONS IN U.S. (MILLIONS)

Source: QuintilesIMS Institute

Prescriptions for hydrocodone and other opioids are likely to fall even further in 2017, because the DEA plans to reduce the supply of almost every Schedule II opioid pain medication by 25 percent or more "to prevent diversion." The 2017 quota for hydrocodone is being reduced by a third, to 58.4 million prescriptions, which the DEA considers an adequate supply.

Overall, QuintilesIMS reported 13 million fewer prescriptions for pain medicines in 2016, “as restrictions on prescribing and dispensing become increasingly common and impactful.” The company includes both narcotic and non-narcotic treatments in its pain medicine category.

Over 7 million more prescriptions were written last year for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 64 million prescriptions were written for gabapentin in 2016, a 49% increase since 2011.

More prescriptions are also being written for ibuprofen, a widely used pain reliever available both by prescription and in over-the-counter drugs. About 44 million prescriptions were filled for ibuprofen in 2016, a 19% increase since 2012.

The shift in prescribing away from opioids is hardly a surprise to pain sufferers. According to a recent survey of over 3,100 patients by PNN and the International Pain Foundation, over 70% said they were no longer prescribed opioids or were getting a lower dose since the CDC guidelines were released. About half of the doctors and pharmacists we surveyed also said they were writing or filling fewer opioid prescriptions, or had stopped them altogether.  

“My doctor cut me off hydrocodone cold turkey last fall leading to an overnight in the hospital emergency room,” a patient with chronic back pain and anxiety told PNN. “For years I have been stable on a mix of hydrocodone and Valium. Last October my doctor said he would only fill one prescription and asked me to make a choice so I stayed with the Valium.”

“With the VA allowing me only 2 hydrocodone per day now, I get very little exercise and stay in bed a lot,” a 70-year old veteran wrote. “My quality of life has gone down considerably. Before the changes, I stayed quite active taking 4 hydrocodone a day.”

“I had an interventional pain management doctor scream at me that the guidelines were mandatory and he refused to write for any type of opioids even though I've been on the same level of hydrocodone for several years,” another patient said.

“I took hydrocodone pain medicine for 25 years as the doctor proscribed. Never called in for more, now I'm having to go a pain doctor and get steroid shots every 3 months,” wrote a patient with lives with chronic back pain.

Overall spending on prescription drugs in the U.S. reached $323 billion in 2016, a 4.8% increase that is less than half the rate of the previous two years. The QuintilesIMS report blames the slowdown in growth on increased competition among drug makers and efforts to limit price increases.

“New medicines introduced in the past two years continue to drive at least half of the total growth as clusters of innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes become accessible to patients,” said Murray Aitken, Senior Vice President and Executive Director, QuintilesIMS Institute.

Ibuprofen No Better Than Placebo for Back Pain

By Pat Anson, Editor

When it comes to treating back pain, anti-inflammatory drugs such as ibuprofen work no better than a placebo, according to new Australian study.

Researchers at the University of Sydney conducted a meta-analysis (a study of studies) of 35 clinical trials involving over 6,000 people with back pain, and found that non-steroidal anti-inflammatory drugs (NSAIDs) provide little benefit. The study was published in the Annals of the Rheumatic Diseases.

“NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo,” wrote lead author Gustavo Machado, PhD, of The George Institute for Global Health. “There is an urgent need to develop new drug therapies for this condition.”

Back pain is the world’s leading cause of disability, with about 80 percent of adults experiencing back pain at some point in their lives.

Opioids are usually not prescribed for simple back pain, leaving patients little alternative but over-the-counter pain relievers such as NSAIDs, a class of drugs that includes both aspirin and ibuprofen. NSAIDs are known to raise the risk of gastrointestinal and cardiovascular problems.

The Australian study found that NSAIDs reduced pain and disability somewhat better than a placebo or dummy medication, but the results were not statistically important.

"NSAIDs do not provide a clinically important effect on spinal pain, and six patients must be treated with NSAIDs for one patient to achieve a clinically important benefit in the short-term," wrote Machado. “When this result is taken together with those from recent reviews on paracetamol (acetaminophen) and opioids, it is now clear that the three most widely used, and guideline-recommended medicines for spinal pain do not provide clinically important effects over placebo.”

The study did not evaluate non-pharmacological treatments for back pain, such as exercise, physical therapy or chiropractic care.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

NSAIDs Raise Risk of Dying From Endometrial Cancer

By Pat Anson, Editor

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) have long been thought to reduce the risk of some cancers. But a surprising new study suggests that regular use of the pain relievers may actually raise the risk of dying for women with endometrial cancer.

Researchers at Ohio State University studied over 4,300 women with endometrial cancer, 550 of whom died during the five-year study. Those who used NSAIDs regularly and had Type 1 endometrial cancer had a 66 percent higher risk of death.

The research findings are published in the Journal of the National Cancer Institute.

"This study identifies a clear association that merits additional research to help us fully understand the biologic mechanisms behind this phenomenon. Our finding was surprising because it goes against previous studies that suggest NSAIDs can be used to reduce inflammation and reduce the risk of developing or dying from certain cancers," said co-author Theodore Brasky, PhD, a cancer epidemiologist at The Ohio State University Comprehensive Cancer Center.

Over 60,000 women are diagnosed with endometrial cancer in the U.S. annually, making it the fourth most common cancer in women and the sixth leading cause of cancer death.

Endometrial cancer begins in the lining of the uterus and grows outward to surrounding organs. Type 1 tumors are less aggressive and are typically confined to the uterus, while Type 2 tumors tend to be aggressive and are at greater risk of spreading.

In the OSU study, the risk of dying was statistically significant in women who reported past or current NSAID use, but it was strongest among patients who used NSAIDs for more than 10 years and had ceased using them prior to their cancer diagnosis.

Interestingly, the use of NSAIDs was not associated with mortality from more aggressive Type 2 cancers.

"These results are intriguing and worthy of further investigation," said co-author David Cohn, MD, director of the gynecologic oncology division at the OSU cancer center. “While these data are interesting, there is not yet enough data to make a public recommendation for or against taking NSAIDS to reduce the risk of cancer-related death."

Aspirin, ibuprofen and other NSAIDs are believed to lower the risk of some cancers by reducing inflammation, which slows the development of blood vessels that support the growth of cancer tumors. Inhibition of inflammation may have the opposite effect in endometrial cancer, but the reasons why are unclear.

Previous studies have shown that NSAIDs have a preventive effect on colorectal cancer and several other cancer types.

“Observational evidence of a chemopreventive effect of aspirin and other NSAIDs has been reported for esophageal, gastric, lung, breast, prostate, and colorectal cancer. Most of these cancers develop after age 60 years,”  researchers at the University of California Irvine reported in The Lancet.

“Given the apparent delay in the chemopreventive effect of NSAIDs (about 10 years), optimum treatment might start at age 40–50 years. Most individuals who develop premalignant lesions do so in their 50s and 60s, several years before the appearance of cancer, so this age range might be the best time for cancer prevention.”

Low-dose aspirin is also believed to have cardiovascular benefits. For that reason, the OSU researchers recommend that women keep taking the pain relievers.  

"It is important to remember that endometrial cancer patients are far more likely to die of cardiovascular disease than their cancer so women who take NSAIDs to reduce their risk of heart attack -- under the guidance of their physicians -- should continue doing so,” said Cohn.

Pain Relievers Linked to Hearing Loss in Women

By Pat Anson, Editor

Long-term use of acetaminophen and ibuprofen raises the risk of hearing loss in older women, according to a new study published in the American Journal of Epidemiology.

Researchers at Brigham and Women’s Hospital in Boston analyzed data from over 55,000 women between the ages of 48 and 73 enrolled in the Nurses’ Health Study, a long-term study that began in 1976.

They found that about 1 in 6 women who used ibuprofen or acetaminophen for at least six years suffered some degree of hearing loss. No such link was found in the women who used regular doses of aspirin.

“Although the magnitude of higher risk of hearing loss with analgesic use was modest, given how commonly these medications are used, even a small increase in risk could have important health implications,” said senior author Gary Curhan, MD, a physician in the Channing Division of Network Medicine at Brigham and Women’s Hospital.

“Assuming causality, this would mean that approximately 16.2 percent of hearing loss occurring in these women could be due to ibuprofen or acetaminophen use.”

Curhan noted the study was limited to mostly older, white women participating in the Nurses’ Health Study and that further investigation with larger and more diverse populations would be needed to better understand the connection between hearing loss and pain reliever use.

The researchers have previously published findings that indicate high frequency use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetaminophen is associated with hearing loss in men and younger women. High doses of aspirin have also been associated with hearing loss.

The new study did not look at why the medications affect hearing, but previous research suggests the pain relievers affect blood and oxygen flow to sensitive parts of the ear that may compromise hearing.

About two- thirds of women in the U.S. over the age of 60 report some degree of hearing loss.

“Hearing loss is extremely common in the United States and can have a profound impact on quality of life,” said Curhan. “Finding modifiable risk factors could help us identify ways to lower risk before hearing loss begins and slow progression in those with hearing loss.”

Many people wrongly believe that over-the-counter pain relievers are relatively safe because they are available without a prescription. But studies have linked NSAIDs and acetaminophen to cardiovascular disease, hypertension, kidney problems and liver failure.

“I worry that people think NSAIDs and acetaminophen are completely safe, and that they don’t need to think about their potential (side effects),” Curhan told Time.  “But particularly for people who are taking them for chronic pain, I try to encourage them to look at why they are having the pain, not what they can take to try to treat the pain.”

The Hidden Dangers of Self-Medicating with OTC Drugs

By James Campbell, MD, Guest Columnist

The Centers for Disease Control and Prevention (CDC) recently unveiled guidelines for primary care physicians on the use of opioids for chronic pain. Not surprisingly, the guidelines urge physicians to first try non-pharmacologic and non-opioid treatments before resorting to opioid therapy.

If you’re one of the millions of Americans living with pain on a daily basis, it’s likely you’re not a stranger to over-the-counter (OTC), non-prescription pain medications such as naproxen (brand name Aleve), ibuprofen (Advil and Motrin), aspirin and acetaminophen (Tylenol).

In fact, most of my patients with chronic pain began their quest for relief with a cocktail of OTC pain relievers, muscle relaxants and even alcohol, before seeking professional help and eventually graduating to prescription treatments such as opioids, anti-depressants and anticonvulsants.

While OTC pain medications are generally safe when taken at their recommended doses, it’s all too common for patients to unknowingly put themselves at risk of a fatal accidental overdose or serious drug-drug interactions by mixing OTC pain medications or taking them in combination with prescription treatments for pain or other common health conditions.

Given the sheer magnitude of serious adverse events and fatalities associated with opioids, the hidden, yet preventable dangers of the pain medications on your pharmacy shelves are not often discussed.

Let’s take one of the most common OTC pain relievers: acetaminophen. When used as directed within the advised dosing guidelines, acetaminophen is safe and effective. However, if a person takes more than one medication that contains acetaminophen and exceeds the maximum recommended dose, they may be at risk of serious liver damage.

This happens so often that acetaminophen overdose is the leading cause of calls to poison control centers in the United States -- more than 100,000 instances per year – and are responsible for more than 56,000 emergency room visits.

In fact, in 2011, in an effort to reduce the risk of severe liver injury from acetaminophen overdose, the Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription medications, including combination acetaminophen and opioid products, to no more than 325 mg per tablet, capsule or other dosage unit.

Then in 2014, the FDA recommended that health care professionals discontinue prescribing and dispensing prescription combination products that contain more than 325 mg of acetaminophen.

While the FDA’s efforts may help curb accidental overdose related to prescription medications that contain acetaminophen (Tylenol with codeine, for example), it does little to address the risks of OTC acetaminophen or other OTC pain medications such as ibuprofen, a type of non-steroidal anti-inflammatory drug (NSAID), which can cause gastrointestinal bleeding and injury, and cardiovascular side effects when taken on a chronic basis.

Drug Interactions

In addition to the risk of overdose, people taking multiple OTC and prescription medications for pain and other conditions are also at risk of serious drug-drug interactions. Simply put, any “drug” – whether it be a medicine, vitamin, supplement or even alcohol – that enters your body and alters your natural internal chemistry has the potential to interact or alter the intended effect or unintended side effect of other medications.

Even though most medications are accompanied by warnings about combining them with other drugs, most vitamins and supplements are not -- so, unless you’re a licensed medical professional, it’s virtually impossible to recognize the potential for drug-drug interactions.

If you’re using OTC medications, whether alone or with prescription medications, to cope with pain on a daily basis, here are three precautionary steps you can take to safeguard yourself against the risk of accidental overdose or drug-drug interactions.

1) Recognize that ALL medications, whether OTC or prescription, can cause harm if used improperly, and the fact that some medications are available without a prescription does not mean they are inherently safe. Read the labels that come with your medications. Tylenol, Advil and Vicodin are household names, so it can be easy to overlook their “generic” names (or the active ingredient in each).

For example, the generic name for Tylenol is acetaminophen, while that of Vicodin is acetaminophen hydrocodone. Without close examination of either label, a person taking Vicodin and Tylenol together could be inadvertently exceeding the recommended dosage of acetaminophen.

2) Consult a medical professional before you take more than one medication on a daily basis. If your chronic pain is being treated by a physician, be sure to tell them (even if it’s on your medical history) about any OTC or prescription medications you are currently taking. This includes vitamins and other supplements that may seem harmless, but could interact with your pain medications.

3) If you are independently treating your chronic pain, make a list of all the medications, vitamins and supplements you take on a regular basis and share them with your local pharmacist. Pharmacists can identify potential drug-drug interactions like taking acetaminophen and ibuprofen on a long-term basis, which can result in an increased risk of developing kidney problems.

The American Chronic Pain Association also recommends using the same pharmacy for all your prescriptions, so that the pharmacist can screen health information and current medications to avoid the pitfalls of overdose and drug interactions.

As a neurosurgeon with a special interest in pain for over 30 years, I’m empathetic to the daily struggle that patients face and their desperate quest for relief, seeking anything and everything that can simply make the pain stop.

For the patients who are fighting this seemingly endless battle with pain without the help of a medical professional, I hope I’ve provided some useful information and practical advice to help avoid serious risks associated with self-medicating. However, people living with moderate to severe chronic pain may benefit from a consultation with a licensed pain management specialist, who can help guide you toward steps that will help reduce your pain. 

James Campbell, MD, has spent the last 30 years pioneering efforts to improve the diagnosis and treatment of patients with chronic pain. 

Dr. Campbell is professor emeritus of Neurosurgery at Johns Hopkins University School of Medicine and is the founder of the Johns Hopkins Blaustein Pain Treatment Center - one of the largest pain research centers in the U.S. He is also a former president of the American Pain Society. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Education Campaign Launched for OTC Pain Relievers

By Pat Anson, Editor

You’ve probably seen the numbers. The Centers for Disease Control and Prevention estimates that over 47,000 Americans died of drug overdoses in 2014. Over 60 percent of them involved some type of opioid, a category that includes both prescribed pain medications and illegal drugs such as heroin.

Rarely mentioned by the CDC is the number of Americans harmed by over-the-counter (OTC) pain relievers such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). Acetaminophen overdoses kill about 150 Americans every year and send 78,000 to the hospital.

With opioids becoming harder to obtain for chronic pain sufferers, many are turning to OTC pain relievers – often excessively. A recent survey of pain patients found that 43% knowingly took more than the recommended dose of OTC pain medicine and 28% experienced complications from an overdose.

To help consumers learn more about the risks posed by OTC pain medications, the Alliance for Aging Research has released two animated videos about how to safely choose, take, and store OTC pain relievers. They explain the difference between acetaminophen – which is widely found in products like Tylenol and Nyquil – and NSAIDs, which includes both ibuprofen and aspirin.

"With so many options, it is important for someone to choose an OTC medication that does the best job of treating their pain, while also being aware of its potential risks to their health," said Lindsay Clarke, Vice-President of Health Programs for the Alliance for Aging.

"For older adults, understanding their options is even more important, as age may increase the risk of certain OTC pain medication side effects. These films offer a great overview of what someone needs to know before taking their OTC pain medication."

The videos were produced with support from McNeil Consumer Healthcare, the maker of Tylenol and Motrin.

A survey of over 1,000 pain sufferers by the American Gastroenterological Association (AGA) found that many routinely ignore OTC medicine labels, putting them at risk of serious side effects such as stomach bleeding, ulcers, liver damage, and even death.

"Pain is incredibly personal, but taking more than the recommended dose of OTC pain medicine can cause significant stomach and intestinal damage among other complications," said Byron Cryer, associate dean at the University of Texas Southwestern Medical Center, Dallas.

Gastroenterologists say most patients who experience complications from overdoses of OTC medicine are trying to manage chronic pain or arthritis. Eight out of ten (79%) also report taking multiple symptom OTC medication in the past year for allergies, cold or flu symptoms – which can greatly increase their exposure to both acetaminophen and ibuprofen.

“It is a growing concern because people living with chronic pain and taking multiple medicines often don’t recognize the side-effects of taking too much,” explained Charles Melbern Wilcox, MD, professor of medicine in the division of gastroenterology and hepatology at the University of Alabama at Birmingham.

New Skin Patch Delivers Pain Relief with Ibuprofen

By Pat Anson, Editor

There are many different types of skin patches already on the market to treat pain --- containing everything from lidocaine to capsaicin to powerful opioids like fentanyl. Now British researchers say they’re a step closer to developing the first transdermal patch containing ibuprofen.

Researchers at the University of Warwick have formed a company called Medherent to produce and patent an adhesive patch that can deliver a high dose of ibuprofen through the skin for as long as 12 hours to treat conditions such as back pain, arthritis and neuralgia.

Their patch differs from others already on the market because the medication is embedded into the polymer matrix that sticks the patch to the patient’s skin. The embedding technology allows the patch to contain 5 to 10 times the amount of analgesic currently used in medical patches.

"Many commercial patches surprisingly don't contain any pain relief agents at all, they simply soothe the body by a warming effect,” says University of Warwick research chemist Professor David Haddleton.

image courtesy of medherent

“Our technology now means that we can for the first time produce patches that contain effective doses of active ingredients such as ibuprofen for which no patches currently exist. Also, we can improve the drug loading and stickiness of patches containing other active ingredients to improve patient comfort and outcome."

The researchers are now testing other analgesics to see if they too can be embedded into the polymers. So far they’ve had good results with methyl salicylate – a wintergreen-scented chemical used in some topical liniments and gels.

“We believe that many other over the counter and prescription drugs can exploit our technology and we are seeking opportunities to test a much wider range of drugs and treatments within our patch," says Haddleton.

In an email to Pain News Network, Medherent’s CEO said the technology is compatible with a wide range of drugs, including opioids. The company is currently seeking partners to help develop the patches.

"Our first products will be over-the-counter pain relief patches and through partnering we would expect to have the first of those products on the market in around 2 years,” said Nigel Davis. “In addition to our pain relief products, our technology also works with drugs in many other therapeutic areas. We can see considerable opportunities in working with pharmaceutical companies to develop innovative products using our next generation transdermal drug-delivery platform."

Adding opioids to the mix is tricky business, because some opioid patches already on the market are being abused. According to CBCNews, transdermal patches containing fentanyl are blamed for over 600 deaths in Canada. Addicts have learned they can cut up fentanyl patches to smoke or ingest them  

Asked if Medherent’s patch technology would prevent similar abuse, Davis said, “We hope so but need to do more work on that before we make claims of that sort. “

Decision on Opioid Implant Nears

Meanwhile, Titan Pharmaceuticals (NASDAQ: TTNP) has announced that the Food and Drug Administration has scheduled a meeting with the company next month to discuss its new drug application for Probuphine, an implant containing buprenorphine, a weak acting opioid used to treat addiction.

Ironically, some addicts have learned they can get high by abusing buprenorphine and it is prized as a street drug that can ease withdrawal pains from heroin. Buprenorphine, which is more widely known under the brand name Suboxone, is currently only available in pills and oral films.

The Probuphine implant would be difficult to abuse. About the size of a matchstick, it is designed to be inserted subcutaneously under the skin of the upper arm, where it can release steady doses of buprenorphine for as long as six months.

Titan and its partner, Braeburn Pharmaceuticals, believe the implant technology could someday be used to deliver other medications, including opioids for pain relief.

image courtesy of titan pharmaceuticals

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study of Probuphine’s effectiveness. Since then, the companies have conducted a study showing that the implant was more effective than buprenorphine tablets in treating addiction. The companies are hoping for FDA approval in 2016.