FDA Alert

FDA Approves First Prescription Nasal Spray to Reverse Opioid Overdose

Jessica Ganga

The FDA has approved the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose. The treatment’s use is approved for adults and pediatric patients aged 12 years and older.

Nalmefene—an opioid receptor antagonist—is typically used to treat acute opioid overdose. If administered quickly, the treatment can reverse the effects of opioid overdose (respiratory depression, sedation, low blood pressure). This is the FDA’s first approval of nalmefene hydrochloride nasal spray for health care and community use.

According to the FDA’s press release, there were more than 103,000 reported fatal overdoses in the United States that occurred in the 12-month period ending in November 2022. These overdoses were found to be driven by synthetic opioids like illicit fentanyl.

“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,” Robert M. Califf, MD, FDA commissioner, said in a press release.

The approval of the nalmefene hydrochloride treatment follows safety and pharmacokinetic studies, and a study that assessed how quickly the drug worked in people who use opioids recreationally.

The most common adverse events included nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, rhinalgia, decreased appetite, erythema, and hyperhyidrosis. Further, patients who are opioid-dependent may experience withdrawal that consists of the following symptoms of body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.



FDA approves prescription nasal spray to reverse opioid overdose. News release. US Food and Drug Administration; May 22, 2023. Accessed May 25, 2023.