FDA Approves Naloxone Nasal Spray for Over-the-Counter Sale

The U.S. Food and Drug Administration (FDA) yesterdayapproved Narcan (naloxone) 4 mg hydrochloride nasal spray for purchase without a prescription. Narcan rapidly reverses the effects of an opioid overdose.“Naloxone is a critical tool in addressing opioid overdoses, and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.The FDA ’s action “paves the way” for Narcan to be sold in drugstores, supermarkets, convenience stores, gas stations, and online, according to the release. The medication will be available in retailers and online by the late summer, and it will still be available as a prescription in the meantime.The over-the-counter (OTC) approval was granted to Emergent BioSolutions, Narcan ’s manufacturer. In February, two FDA advisory committeesrecommended Narcan be made available without a prescription.According to anews release from the company, the OTC product will have the same formulation, device design, and prescription strength as the original product.Cavazzoni said in the FDA release that the agency is working with its federal partners to ensure continued access to naloxone during Narcan ’s transition to OTC status. “Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturer...

Source: Psychiatr News - March 30, 2023 Category: Psychiatry Tags: APA Emergent BioSolutions FDA Food and Drug Administration naloxone narcan opioid overdose OTC over the counter medication Robert Califf substance use disorder Source Type: research