FDA Approves Opioid Overdose Reversal Injection for Ages 12+ Amid Rising Teen Deaths

To combat the ongoing opioid crisis in the United States, the U.S. Food and Drug Administration (FDA) has approved Zurnai, the first nalmefene hydrochloride auto-injector for emergency treatment of known or suspected synthetic opioid overdoses in adults and pediatric patients aged 12 years and older. The approval brings the addition of another tool in the FDA’s toolbox and plan to broaden access to overdose reversal agents, including naloxone and nalmefene. The approval of Zurnai, a single-dose, pre-filled auto-injector available only by prescription, follows the FDA’s May 2023 approval of the first nasal spray formulation of nalmefene. “The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene,” FDA Commissioner Robert Califf said in a press release. “Today’s approval adds a new nalmefene product and route of administration to support greater options for opioid overdose reversal. Since launching the FDA Overdose Prevention Framework in 2022, the agency continues to build upon efforts that address the overdose crisis currently impacting the nation.”...