FDA Pushing for Over-The-Counter Sales of Naloxone

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has launched an “unprecedented” effort to support over-the-counter sales of naloxone, an overdose recovery drug credited with saving thousands of lives. The FDA has developed new drug labeling — at taxpayer expense — to encourage drug makers to start selling naloxone without a prescription.

“This is the first time the FDA has proactively developed and tested a DFL (drug facts label) for a drug to support development of an OTC product. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible.”

FDA proposed label for evzio

Curiously, one of the labels the FDA developed would support sales of Evzio, a controversial naloxone auto-injector that sells for about $3,700.

A recent U.S. Senate report accused Kaleo – the company that makes Evzio – of inflating its price by 600% to “capitalize on the opportunity” of a “well established public health crisis.” The report estimates Medicare and Medicaid paid over $142 million in excess costs to Kaleo for its Evzio injectors.

Kaleo has since announced plans for a generic version of Evzio to be available in mid-2019 at a reduced price of $178.

The FDA has also developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135.

Last month, federal health officials called naloxone an “essential element” of government efforts to reduce deaths from opioid overdoses, and urged doctors to co-prescribe naloxone to pain patients talking relatively modest doses of 50 morphine milligram equivalents (MME) or more per day.

The drumbeat for naloxone comes at a time when sales are already booming. According to the healthcare data firm IQVIA, naloxone sales grew from $21 million in 2011 to over $274 million in 2016, and are projected to reach $500 million by 2020. Many of these purchases are made through Medicare or Medicaid, or government funded grants that supply naloxone at no cost to first responders, hospitals and addiction treatment clinics. 

According to one estimate by the CDC, naloxone reversed over 26,000 opioid overdoses from 1996 to 2014, and advocates say the drug has likely prevented thousands of deaths since then.

Earlier this month, naloxone was credited with saving a dozen lives at a suspected fentanyl mass overdose that left one man dead in Chico, California.

“Without that, I’m convinced that we would have had certainly four or five, if not more, additional fatalities,” Chico Police Chief Michael O’Brien told The Los Angeles Times. “There’s no doubt it saved lives.”

Is Naloxone Increasing Opioid Abuse?

There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the opioid epidemic and may in fact be making it worse.

In a study recently published by SSRN, an open access online journal, two economics professors said naloxone may raise the risk of an overdose by providing a “safety net” to opioid abusers -- in effect giving them a second chance to abuse more drugs. In an anlaysis of Google search results, they found anecdotal evidence that drug crimes and overdoses increased in states where there was easy access to naloxone.

“Expanding naloxone access increases opioid abuse and opioid-related crime, and does not reduce opioid-related mortality. In fact, in some areas, particularly the Midwest, expanding naloxone access has increased opioid-related mortality. Opioid-related mortality also appears to have increased in the South and most of the Northeast as a result of expanding naloxone access,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Our results show that broad naloxone access may be limited in its ability to reduce the epidemic’s death toll because not only does it not address the root causes of addiction, but it may exacerbate them.”

Doleac and Mukherjee say naloxone may give drug abusers a false sense of security, encouraging them to seek “a higher high” with more dangerous drugs like illicit fentanyl. The researchers said public health officials should prepare for these unintended consequences by offering addiction treatment along with naloxone.

Government-supported efforts to increase naloxone sales are not confined to the federal government. As PNN has reported, a new state law in California requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an opioid overdose. Nothing in the law requires patients to obtain naloxone, yet some pain sufferers say they are being “blackmailed” by pharmacists who refuse to fill their opioid scripts unless naloxone is also purchased. Patients around the country report similar experiences.