HQ Team
August 8, 2024: US drugmaker Purdue Pharma’s injection to treat opioid overdose in adults and patients 12 years or older, got the country’s drug regulator’s approval.
The company’s Zurnai drug is the first nalmefene hydrochloride auto-injector for emergency treatment for overdose, according to a statement from the Food and Drug Administration.
The FDA permitted this application under its 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 federal agency approved the first nasal spray formulation of nalmefene in May 2023.
Illicit fentanyl
Drug overdose persists as a major public health issue in the U.S., with more than 107,000 reported fatal overdoses occurring in 2023, primarily driven by synthetic opioids like illicit fentanyl.
Nalmefene and naloxone are two available options to reverse opioid overdose.
“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,” said FDA Commissioner Robert M. Califf, MD.
“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.”
Administer quickly
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 (hypotension).
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.
The approval of Zurnai was 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.
Adverse reactions
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.
Other adverse reactions include palpitations, ringing or buzzing in the ear (tinnitus), ear discomfort, feeling abnormal, burning sensation, hot flush and irritability.
The use of nalmefene hydrochloride in opioid-dependent patients may result in opioid withdrawal characterized by body aches, diarrhoea, fast heart rate, fever and runny nose.
Signs also include sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
