FDA Alert

FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose

Anthony Calabro, MA

On August 7, the FDA approved the first nalmefene hydrochloride auto-injector for the emergency treatment of opioid overdose in those 12 years of age and older. The FDA approved the first nasal spray formulation of nalmefene, an opioid receptor antagonist, in May 2023.

According to the FDA, more than 107,000 fatal overdoses occurred in 2023. With two options to reverse opioid overdose—nalmefene and naloxone—the FDA noted in its press release that the goal is to increase the availability and accessibility of both options to curb opioid overdose, which is primarily driven by synthetic opioids like illicit fentanyl.

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

>> FDA Alert: Second OTC Naloxone Nasal Spray Approved by FDA

The nalmefene hydrochloride auto-injector delivers 1.5 mg of nalmefene subcutaneously or intramuscularly. A single-dose, pre-filled auto-injector is only available by prescription.

The FDA approval comes after both safety and pharmacokinetic studies, as well as a study that assesses how quickly the product works on healthy individuals, the FDA noted in the press release.

The most common adverse reactions included feeling hot, dizziness, nausea, headache, chills, vomiting, allodynia, palpitations, tinnitus, feeling abnormal, burning sensation, hot flush, and irritability.

Nalmefene hydrochloride use among patients who are opioid-dependent may result in opioid withdrawal, which could lead to 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.

Reference:
FDA approves first nalmefene hydrochloride auto-injector to reverse opioid overdose. News release. US Food and Drug Administration; August 07, 2024. Accessed August 21, 2024.https://www.fda.gov/news-events/press-announcements/fda-approves-first-nalmefene-hydrochloride-auto-injector-reverse-opioid-overdose.