FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
SILVER SPRING, Md., May 22, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.
- This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.
- "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, M.D.
- "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."
- If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (i.e., hypotension).