On August 7, the U.S. Food and Drug Administration (FDA) approved the nalmefene hydrochloride auto-injector that is used in the treatment of opioid overdose.
The treatment is used to treat opioid overdose in adults and children 12 years of age and older.
According to the press release, drug overdose continues to be a major public issue and this auto-injector makes way for another option to address the crisis.
“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.”
When quickly administered, it can reverse the effects, including respiratory depression, sedation and low blood pressure (hypotension), the FDA said.
The FDA granted the application Fast Track status to get it to market faster.
“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare providers or anyone in the community,” said Craig Landau, MD, President and CEO, Purdue. “Zurnai can be an important new tool to save lives in critical moments. We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the Company.”
The product will go by the name Zurnai and has been awarded to Purdue Pharma L.P.
Zurnai will be available in 2025