A second naloxone nasal spray gets FDA fast track for OTC clearance

A nasal spray version of naloxone (Rivive—Harm Reduction Therapeutics) is now on the FDA fast track for OTC clearance. According to the manufacturer, FDA is aiming for April 28, 2023, as an approval date after priority review. With cost and access in mind, Harm Reduction Therapeutics also noted that it would price the overdose antidote at about $18 per dose for sale to pharmacies, public-sector workers, and advocacy organizations. The nonprofit company will also donate one-tenth of its production, which is slated to reach 2 million doses annually.

This approval shortly follows FDA’s decision in late 2022 to put an OTC version of naloxone nasal spray (Narcan—Emergent BioSolutions) on the fast track to approval. That opioid overdose antidote tentatively could receive clearance early this spring.

Another company, Pocket Naloxone Corp., has submitted its application for a nasal-swab version of naloxone that it says would be more affordable than the sprays and faster-acting than prescription formulations.