FDA Advisory Panel Recommends Approval for Over-the-Counter Narcan

Last week the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously, 19-0, to recommend that Narcan (naloxone HCl) 4 mg nasal spray be made available without a prescription, Emergent BioSolutionsannounced. The medication reverses an opioid overdose by blocking the effects of opioids.The FDA is not bound by the committees ’ guidance but will take their advice into consideration when it makes its decision on whether to make the drug available over the counter (OTC). If approved, Narcan would be the first OTC naloxone product. The FDA’s decision is expected by March 29.The recommendation comes after Emergentpresented an overview of its OTC development program, medical need, human factors study data, and seven years of postmarketing safety data.“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” said Joshua Lynch, D.O., E.M.T.-P., of the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, in the announcement. “The reality is accidenta l overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”According to areport inSTAT, while Nar...
Source: Psychiatr News - Category: Psychiatry Tags: Food and Drug Administration naloxone narcan opioid overdose over-the-counter STAT Source Type: research