Opioid Promotion Cited in FDA Warning Was Stopped in 2019

By Pat Anson, PNN Editor

A California pharmaceutical company that received a warning letter from the Food and Drug Administration over its promotion of a controversial opioid painkiller stopped using the marketing material over a year ago.

The FDA sent the warning letter to AcelRx Pharmaceuticals last week. The agency told the company to stop making “false and misleading claims” about Dsuvia, a potent opioid tablet used to relieve acute pain in hospital settings.

The “Tongue and Done” banner ads and tabletop displays emphasized how easy Dsuvia is to administer by using a plastic applicator that releases a single tablet directly into a patient’s mouth. The FDA said the promotions were misleading and dangerous.

“AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it,” the FDA said in a statement.

“This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.”

The letter warns AcelRx to either stop using the marketing material or cease distributing Dsuvia. It gave the company 15 days to respond or face “further regulatory action.”    

ACELRX PROMOTION

But in a filing with the Securities and Exchange Commission, AcelRx said it could “easily address” the FDA’s concerns because it stopped using the “Tongue and Done” promotions in late 2019.

“The Company intends to respond to the FDA within the timeframe requested in the Letter and seek guidance and clarification from the FDA on the concerns raised in the Letter,” the SEC filing states. “The Company cannot give any assurances, however, that the FDA will be satisfied with its response to the Letter or that such response will resolve the issues identified in the Letter.”

Few Adverse Events Involve Dsuvia

The FDA approved the use of Dsuvia in 2018 over the objections of anti-opioid activists who said it was a “dangerously unnecessary opioid medication" that would be diverted, abused and lead to more overdoses. There is little evidence any of that has occurred.

Dsuvia contains sufentanil, an opioid 10 times stronger than fentanyl. It was developed to fulfill an unmet need in military and civilian hospitals, where patients need quick relief from acute trauma pain and can’t wait for opioids to be administered intravenously. Each Dsuvia tablet comes in a single dose applicator. The tablets quickly dissolve under the tongue and are not available for home use.

Those safety measures appear to be working. The FDA’s Adverse Events Reporting System lists only six cases involving Dsuvia in 2019 and 2020. There were no deaths and none of the cases were considered serious.

AcelRx recently published the results of a clinical study that showed surgery patients treated with Dsuvia used significantly fewer opioids than those treated with traditional IV opioids. They were also discharged sooner.

The FDA’s belated warning letter to AcelRx about its Dsuvia marketing comes as the agency faces renewed scrutiny for its regulation of opioids.

Acting FDA Commissioner Dr. Janet Woodcock is reportedly under consideration by President Biden for a formal nomination to the job, which has drawn the ire of some anti-opioid activists. A letter sent to the Acting Secretary of Health and Human Services accuses Woodcock of “dereliction of duty” for failing to address the opioid crisis by halting the approval of new opioids. Woodcock has been Director of the FDA’s Center for Drug Evaluation and Research for over 25 years.

Opioid Hysteria and the Demonizing of Dsuvia

By John Burke, Guest Columnist

Recently the FDA approved a new sublingual formulation of sufentanil -- called Dsuvia -- for the management of moderate to severe acute pain in hospital-like settings. This would include surgical centers and emergency departments.

When the FDA announced this approval, several so-called experts claimed that Dsuvia – which is a potent opioid – would worsen the already out of control opioid problem. They said it would quickly find its way to the streets of America and kill even more of our citizens addicted to opioids. They can’t imagine why the FDA would approve such a killer drug!

Dsuvia was originally developed by AcelRx Pharmaceuticals, in cooperation with the U.S. Department of Defense, to treat battlefield wounds. The single dose formulation is designed to enter your body and provide pain relief faster than the traditional intramuscular injections that are now standard in treating traumatic injuries.

I can only imagine the horrendous wounds that are present on the battlefield. Offering faster pain relief seems like a great option, to say the least!  

ACELRX PHARMACEUTICALS

Dsuvia will also be used in our nation’s emergency departments and other healthcare facilities to offer faster pain relief to patients who suffer traumatic injuries. The drug will not be available in retail pharmacies or for most prescribers to order up for a patient. Doctor shoppers, script scammers and others that prey on retail pharmacies will have no access to this pain reliever. Those involved in armed robberies or burglaries of retail pharmacies will also have zero access.

Who will have access to Dsuvia are healthcare employees -- nurses, doctors and other medical professionals who already have access to a whole host of opioid drugs. There is no question that Dsuvia could potentially be a target of a small group of professionals who suffer from addiction problems. However, the illegal diversion and sale of this specific medication seems less likely in healthcare facilities.

Dsuvia will be more easily identified when it is diverted due to its limited availability and usage. Addicted healthcare employees will likely opt for more commonly used opioids like morphine and hydromorphone rather than a rarely used medication that will be easily missed when diverted.

The other part of this equation, that was either not considered by critics or didn’t suit their narrative, is that diversion inside healthcare facilities virtually always involves self-addiction. This means that even if an opioid is stolen by an employee inside one of these facilities, it will rarely make it to the street and cause more deaths.  

AcelRx has already developed a Risk Evaluation and Mitigation Strategy (REMS) involving RADARS, a nationwide drug abuse surveillance system, to monitor any diversion of Dsuvia and provide quarterly reports to law enforcement. In the interest of full disclosure, I am on the Scientific Advisory Board of RADARS.

Dsuvia has great potential to provide quick relief to trauma patients in a focused setting. Its diversion potential, especially to the public, is almost nil. Demonizing a drug without any real knowledge of its legal distribution and potential for diversion is irresponsible to say the least.

The drug problem in America primarily involves street drugs such as heroin, illicit fentanyl, and more recently crystal methamphetamine and cocaine. Even as the prescribing of opioids has dropped over 30% in recent years, drug deaths continued to rise. The reason is the increased supply of street drugs supplied by cartels that continue to profit from our nation’s addiction.

Put the blame where it belongs, and don’t ostracize a legitimate new pain drug that any of us might need in an emergency.

John Burke spent nearly 50 years in drug and law enforcement in southwestern Ohio. John is a former president of the National Association of Drug Diversion Investigators and is the president and founder of the International Health Facility Diversion Association, a non-profit devoted to the issues surrounding the diversion of controlled substances from healthcare facilities.

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

FDA Approves Controversial New Opioid

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial new opioid drug intended to relieve moderate to severe pain in wounded soldiers and trauma patients. 

Dsuvia is a tablet form of the potent opioid sufentanil. It was developed by AcelRx Pharmaceuticals and the Department of Defense – in part to treat battlefield wounds – but became embroiled in the national hysteria over opioid drugs and addiction.

Dsuvia was developed to fulfill an unmet need in military and civilian hospitals, where patients in acute pain are usually treated with opioids intravenously or with a pill.

Each Dsuvia tablet comes in a single dose plastic applicator. The tablet is taken sublingually under the tongue, where it quickly dissolves and is absorbed into the body.

“There is currently no way available to rapidly treat your pain without sticking you with a needle,” said Dr. Pamela Palmer, an anesthesiologist who co-founded AcelRx and is Chief Medical Officer.

ACELRX image

“If you broke your femur and are obese or elderly or on a blood thinner, that can be very painful with a lot of bruising. If you take a pill, you have to swallow it with water and wait for it to kick in, which could take up to an hour. Right now, that’s all that’s available. For the first time, we’ve developed a small tablet that goes under the tongue and dissolves in about six minutes.”

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds,” said FDA commissioner Scott Gottlieb, MD.

Dsuvia’s efficacy and safety were tested in two placebo-controlled studies with over 200 patients. The company said the drug was well-tolerated and effective across a range of patient ages and body sizes.

But because Dsuvia is so potent – it’s 10 times stronger than fentanyl – it drew the ire of critics who believe diversion is inevitable.

“We know from looking at other potent opioids that have been put on the market in the last four years that once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market,” Raeford Brown, MD, told ABC News.

Brown is chairman of the FDA advisory committee that voted 10-3 to recommend approval of Dsuvia.  Brown was not present for the vote, but called on the FDA to ignore the panel’s recommendation and stop the approval of “this dangerously unnecessary opioid medication."

“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year,” said Brown.

Politicians also weighed in.

“An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused and a thousand times more likely to kill,” said Sen. Ed Markey (D) Massachusetts. “It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts.”

The FDA is requiring that Dsuvia not be dispensed for home use, should only be administered by a healthcare provider, and should not be used for more than 72 hours. Palmer says extra precautions would also be taken by distributors, wholesalers and hospitals to prevent theft and diversion.

“I’m not saying that drugs delivered to hospitals never get stolen or abused, but that’s a tiny sliver” of the opioid problem, she said.