FDA has reportedly put an OTC version of naloxone nasal spray (Narcan—Emergent BioSolutions) on the fast track to approval.
Through the agency’s priority review process, the opioid overdose antidote tentatively could receive clearance early this spring. If so, Emergent BioSolutions would be the first of several makers to get a green light in response to regulators’ call for OTC formulations of overdose-reversal agents, which are needed to counter a surge in overdoses due to counterfeit fentanyl.
FDA informed prescription drug manufacturers in November that once enough data is available to support approval of a nonprescription naloxone product, any clinically comparable products sold only with a physician’s order would be viewed as mislabeled. Per the vision of FDA Commissioner Robert Califf, MD, naloxone should be as commonplace and accessible as defibrillators.