The FDA approved Zurnai, a nalmefene hydrochloride auto-injector, for emergency opioid overdose treatment in individuals aged 12 and older.
RT’s Three Key Takeaways:
- FDA Approval: The FDA has approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of opioid overdose in individuals 12 years and older.
- Usage and Administration: Zurnai delivers a 1.5 mg dose of nalmefene under the skin or into muscle and is designed for single-dose use, available by prescription.
- Impact and Accessibility: The approval, supported by various studies, aims to provide a tool for healthcare professionals and the community in addressing the opioid overdose crisis.
The US Food and Drug Administration (FDA) approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
The agency approved the first nasal spray formulation of nalmefene in May 2023.
Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure. The newly approved product delivers 1.5 milligrams of nalmefene under the skin or into muscle. Zurnai is a single-dose, pre-filled auto-injector and is available only by prescription.
Zurnai for Opioid Overdose
The approval of Zurnai is supported by safety and pharmacokinetic studies, as well as a study in healthy individuals who use opioids recreationally, to assess how quickly the product works. The most common adverse reactions are feeling hot, dizziness, nausea, headache, chills, vomiting, feeling pain from actions that aren’t typically painful such as lightly touching your skin, palpitations, ringing or buzzing in the ear, ear discomfort, feeling abnormal, burning sensation, hot flush and irritability.
The use of nalmefene hydrochloride in patients who are opioid-dependent may result in opioid withdrawal characterized by the following signs and symptoms: body aches, diarrhea, fast heart rate (tachycardia), fever, runny nose, sneezing, goosebumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
The FDA granted this application Fast Track and Priority Review designations, which expedite the development and review of drugs that have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.
The FDA granted approval of Zurnai to Purdue Pharma LP.
“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare professionals or anyone in the community,” says Craig Landau, MD, president and CEO, Purdue, in a release. “Zurnai can be an important new tool to save lives in critical moments. We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the company.”
Photo 177372988 © Olan Dah | Dreamstime.com
