Zurnai is indicated for treating suspected or known opioid overdose in adults and pediatric patients aged 12 years and older.
It is not a substitute for emergency medical care and is intended for administration immediately as emergency therapy in settings where there may be presence of opioids.
The FDA approval follows the introduction of the first nasal spray formulation of nalmefene in May last year.
Nalmefene and naloxone are two pharmacological options for reversing opioid overdoses. Nalmefene, an opioid receptor antagonist, is effective in treating acute opioid overdose.
Zurnai, which delivers 1.5mg of nalmefene subcutaneously or intramuscularly, is a single-dose, pre-filled auto-injector and requires a prescription.
The FDA’s approval of Zurnai is based on safety and pharmacokinetic studies, alongside a study involving healthy individuals who use opioids recreationally, to determine the product’s onset of action.
Common adverse reactions include feeling hot, dizziness, headache, nausea, palpitations, chills, vomiting, allodynia, tinnitus, ear discomfort, burning sensation, hot flush, feeling abnormal, and irritability.
Administering nalmefene hydrochloride to opioid-dependent patients may precipitate withdrawal symptoms such as body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, among others.
US FDA Commissioner Robert Califf said: “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.
“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.”