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 agency said at the time that the statistics highlighted a severe public health crisis that began in 2017 and continues today.
The agency added that while it initially focused on prescription opioids, it now primarily revolves around illicit opioids like fentanyl. Nalmefene, the drug approved in the new injectable form this week, is an opioid receptor antagonist used to treat acute opioid overdoses, according to the agency. It works by reversing the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure, if administered quickly.
The approved product delivers 1.5 milligrams of nalmefene subcutaneously or intramuscularly. This means it can be injected under the skin or into the muscle, allowing for rapid intervention during an overdose emergency.
Previously, nalmefene was available as a nasal spray,.