FDA approves overdose reversing nasal spray, Opvee

By Brian Ward

On May 22, the FDA approved a nasal spray that can be used for emergency treatment for overdoses caused by fentanyl and other opioids. The medicine, Opvee, was first approved as an injection in the 1990s, but the FDA announcement means it can be given as a prescription nasal spray.

This is the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults, the FDA stated in a press release. The spray can be given to patients 12 years or older.

“The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” said FDA Commissioner Robert M. Califf, MD, in the press release. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups, and emergency responders.”

According to the CDC, over 109,000 fatal overdoses were recorded in 2022, with almost 80,000 of those deaths related to opioids.

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Patient Safety, Quality & Errors

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