Naloxone Nasal Spray Gets Nod by FDA

Last month, the Food and Drug Administration (FDA) approved Narcan nasal spray—the first nasal spray version of naloxone hydrochloride, a medication that can stop or reverse the effects of an opioid overdose.

“This easy-to-use intranasal formulation will no doubt save many lives,” Nora Volkow, M.D., director of the National Institute on Drug Abuse (NIDA) told NIDATV. NIDA played a critical role in the development of the intranasal spray, working with Adapt Pharma Inc. to design and conduct the clinical trials to evaluate whether the nasal formulation delivers naloxone as quickly as formulations previously approved by the FDA.

Until this approval, naloxone was available only in injectable forms, most commonly delivered by an auto-injector that was approved in 2014. However, according to the FDA, concerns over using a contaminated needle stick led a growing number of people to use unapproved naloxone kits that combined the injectable formulation of naloxone with an atomizer that could deliver the drug nasally. The approval of the nasal spray formulation means those with or without medical training will now have access to an FDA-approved product that does not require assembly and delivers a consistent, measured dose when used as directed.

The approval of Narcan nasal spray was based on two pharmacokinetic studies that compared the speed of drug delivery of varying doses of Narcan nasal spray (ranging from 2 mg to 8 mg naloxone in 0.1 ml nasal spray) with the FDA-approved naloxone (0.4 mg) injectable formulation.

The results showed that administration of Narcan nasal spray in one nostril (while patient lies on his or her back) delivered approximately the same levels or higher of the medication as a single dose of the FDA-approved naloxone intramuscular formulation.

In addition, the nasal formulation works as fast as the injectible formulation, Phil Skolnick, Ph.D., D. Sc., director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse at NIDA, said on NIDATV. “It is taken from the nasal passage, goes into the blood, and then to the brain,” bypassing the lungs, which may be severely impaired during drug overdose, he explained.

Other trials were conducted to assess the level of ease or difficulty of administering Narcan nasal spray. Over 90 percent of the 175 trial participants successfully simulated administering the medication.

“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.

According to the Centers for Disease Control and Prevention, the number of drug overdose deaths has steadily climbed for more than a decade.

“Combating the opioid abuse epidemic is a top priority for the FDA,” Stephen Ostroff, M.D., acting commissioner of the FDA, said in a press statement. “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.”

Narcan nasal spray is distributed by Adapt Pharma Inc. ■