US: FDA Approves Nalmefene Auto-Injector for Opioid Overdose

Opioid antagonist previously approved in injectable and nasal spray formulations

The FDA approved the first nalmefene hydrochloride auto-injector (Zurnai) for use as an emergency treatment for opioid overdose in adults and children 12 years of age and older, the agency announcedopens in a new tab or window Wednesday.

Nalmefene is an opioid receptor antagonist used to treat acute opioid overdose, initially approved in 2022 as an injectionopens in a new tab or window for use by healthcare professionals and, since May 2023, as a nasal spray formulation (Opvee)opens in a new tab or window. If administered quickly, the treatment can reverse the effects of opioid overdose, such as respiratory depression, sedation, and hypotension.

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