Fast-tracked heroin antidote approval puts opioid epidemic on route to recovery

Narcan® nasal spray, a nasal spray version of naloxone hydrochloride, a life-saving medication that can either stop or reverse the effects of an opioid overdose, is now approved by the FDA. Until now, naloxone was only approved in injectable forms, which are most commonly delivered via syringe or auto-injector. The FDA approved the nasal spray to make the delivery of the medication a safer process and eliminate the potential risk of a contaminated needle stick.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner of the FDA. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

Combatting abuse

The FDA’s move to approve Narcan nasal spray is meant to provide help to a fast spreading epidemic of opioid abuse. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin. Drug overdose deaths, driven largely by prescription drug overdoses such as opioids, are now the leading cause of injury death in the United States—surpassing motor vehicle crashes, according to the FDA.

The Narcan nasal spray will be easier to use, as it can be administered by anyone, even individuals without any medical training. Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed.

Fast track

One way the government is combatting the statistic is by approving drugs like Narcan, which, if administered quickly, can counter opioid overdose effects, usually within two minutes. The FDA granted fast-track designation and priority review for Narcan nasal spray earlier in 2015. Fast track is a process designed to facilitate development and expedite review of drugs intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. Narcan nasal spray approval took place in less than four months, which is significantly faster than the product’s prescription drug user fee goal date of January 20, 2016.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication—a critical attribute for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.