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# FDA OKs Opiant Pharma’s Opioid Overdose Spray
- URL: https://www.fdaweb.com/fda-oks-opiant-pharmas-opioid-overdose-spray/
- Published: 2023-05-22T12:00:00.000Z
- Updated: 2026-09-14T18:33:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154507

FDA has approved an Opiant Pharmaceuticals NDA for Opvee (nalmefene HCl) nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmafene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders,” FDA commissioner **Robert Califf** is quoted in a [release](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjbrY3O-on%5FAhXYD1kFHZ2ZAVMQFnoECA4QAQ&url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-prescription-nasal-spray-reverse-opioid-overdose&usg=AOvVaw146IcYoAEbbAPtbJXM3fEg) as saying.

Nalmefene is an opioid receptor antagonist that, if administered quickly, can reverse an opioid overdose, FDA says. It is available by prescription and is intended for use in health care and community settings. Approval was based on safety and pharmacokinetic studies, as well as a study in those who use opioids recreationally to assess how quickly the drug works. The agency says the most common adverse reactions include “nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose (rhinalgia), decreased appetite, skin redness (erythema) and excessive sweating (hyperhidrosis).”