FDA grants priority review to over-the-counter Narcan nasal spray

The FDA has accepted a supplemental new drug application for Narcan nasal spray as an over-the-counter emergency treatment for opioid overdose.

The agency granted the application priority review. If approved, Narcan (naloxone hydrochloride, Emergent BioSolutions) would be the first 4 mg naloxone nasal spray available OTC in the U.S., according to a press release from the manufacturer.

The Prescription Drug User Fee Act goal date has been set for March 29, 2023.

“We are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country,” Robert G. Kramer, president and CEO of Emergent BioSolutions, said in the press release. “We look forward to working with the FDA to advance our application under priority review designation and believe in the scientific evidence that supports the efficacy and safety of Narcan nasal spray as an over-the-counter option for opioid overdose reversal.”

The application’s acceptance comes weeks after the FDA announced findings from a preliminary assessment indicating that certain naloxone products could be approvable for over-the-counter use. They FDA encouraged manufacturers of prescription naloxone products to contact the agency “as early as possible to initiate a discussion about a possible switch” to OTC use.

The application included data from human factors studies conducted, according to the release, “as well as more than 5 years of post-marketing data to demonstrate the safe and effective use of Narcan.”

“Since its approval in 2015, Emergent has distributed millions of prescription Narcan devices across the U.S. to national, state and local government health departments and first responders closest to at-risk populations, including public health clinics, fire departments and police departments,” according to the release. “Accidental overdoses can happen to anyone, anywhere, at any time, and by shifting to OTC status, increased access to Narcan will help address patient needs as the opioid epidemic continues to evolve.”