Emergent makes history with first FDA nod for over-the-counter naloxone

A new day has dawned in the fight against the U.S. opioid epidemic after the FDA approved the first over-the-counter naloxone product. And the gold medal goes to Emergent BioSolutions.

Wednesday, the U.S.’ drug regulator blessed Emergent’s 4mg Narcan nasal spray with a nonprescription nod, teeing up direct-to-consumer sales at places like drug stores, convenience stores, supermarkets and gas stations.

Ultimately, the timeline on which the product will be made available at stores—as well as its price—is up to Emergent. An Emergent spokesperson declined to comment on the OTC product’s cost, but confirmed over email that it will be different than the out-of-pocket price most patients pay for the prescription version.

Emergent expects over-the-counter availability to come “by late summer of this year,” the company added in a press release. Prior to the product’s debut, Emergent must make manufacturing changes on the nonprescription product's packaging and adjust its supply chain.

In the interim, FDA will continue to help facilitate the availability of traditional naloxone nasal spray, the agency said in a statement.

Other formulations and dosages of naloxone will remain prescription only, though there are access laws that technically permit pharmacies across all 50 states to dispense the emergency drug without a doctor’s note.

Drug overdoses are a major public health problem in the United States. The FDA in its approval release noted that in the 12 months ending in October 2022, the U.S. recorded more than 101,750 fatal overdoses, most of which were fueled by synthetic opioids.

Emergent, for its part, says the epidemic is “escalating in the U.S. with the rise in synthetic opioids.”

“Today’s landmark FDA OTC approval for Narcan nasal spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” Robert Kramer, Emergent’s CEO, said in a statement. He stressed that the company’s work is not done, noting that “now” is the time to come together with government, retail chains and advocacy groups to increase naloxone access and educate the public on the risks of opioid overdoses.

The FDA previously approved Emergent’s 4mg nasal spray as a prescription product back in 2015. To win the OTC designation, Emergent offered up data demonstrating the drug is safe and effective, and that the drug’s label is clear enough to facilitate proper use by the average person. The company’s OTC application snagged a priority review in December and unanimously won over an FDA panel of outside experts in February.

FDA has been angling for a nonprescription naloxone switch for years. Back in November, the regulator released its preliminary assessment that certain naloxone products “may be approvable”—i.e., safe and effective—for over-the-counter use.

Elsewhere on the over-the-counter front, nonprofit pharma company Harm Reduction Therapeutics recently tapped CDMO juggernaut Catalent to help crank out commercial supply of its prospective opioid antagonist RiVive. The move came shortly after Harm Reduction won a priority review on its over-the-counter naloxone application at the FDA.

The company figures its product could score FDA approval in July 2023, which would tee up a U.S. launch in “early 2024,” Harm Reduction said in a press release.