FDA approves first Nalmefene Hydrochloride auto-injector to reverse opioid overdose

The US FDA approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023. 

Drug overdose persists as a major public health issue in the US, with more than 107,000 reported fatal overdoses occurring in 2023, primarily driven by synthetic opioids like illicit fentanyl. Nalmefene and naloxone are two available options to reverse opioid overdose. The FDA has worked to increase the availability and accessibility of both options to encourage harm reduction and reduce overdose death. 

Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (hypotension). The newly approved product delivers 1.5 milligrams (mg) of nalmefene under the skin (subcutaneous) or into muscle (intramuscular). Zurnai is a single-dose, pre-filled auto-injector and is available only by prescription. 

The FDA granted this application Fast Track and Priority Review designations, which expedite the development and review of drugs that have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition. 

The FDA approved Zurnai to Purdue Pharma