Agency Continues to Support Development of Overdose Reversal Drugs including Naloxone and Nalmefene SILVER SPRING, Md. , Aug. 7, 2024 /PRNewswire/ -- Today, the U.
S. Food and Drug Administration 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 U.S., 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 availability and accessibility of both options to encourage harm reduction and reduce overdose death. "The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene.
Today's approval adds a new nalmefene product and route of administration to support greater options for opioid overdose reversal," said FDA Commissioner Robert M. Califf , M.D.
"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." 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 opi.