Purdue Pharma said that the US Food and Drug Administration (FDA) has approved its new drug application for the Zurnai (nalmefene injection) Auto-Injector for opioid overdose.
Zurnai is now authorised for the emergency treatment of known or suspected opioid overdose, whether caused by natural or synthetic opioids, in adults and paediatric patients aged 12 years and older.
The single-dose, pre-filled auto-injector, administers a single dose of 1.5mg of nalmefene hydrochloride per use under the skin or into muscle.
It is specifically used in cases of respiratory and/or central nervous system depression as an emergency therapy only by prescription.
In May 2023, the FDA approved the first nasal spray formulation of nalmefene.
Nalmefene and naloxone are two available options for reversing opioid overdose.
FDA Commissioner Robert Califf said: “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.”
The approval of the injection is supported by safety and pharmacokinetic studies. It was also based on a study conducted in healthy individuals who use opioids recreationally, to evaluate the product’s action time.
Provisional data for the 12 months ending February this year indicated that about 90% of opioid overdose deaths involved synthetic opioids.
Purdue Pharma currently distributes nalmefene hydrochloride injection in single-dose vials containing 2mg/2mL.
These vials are intended for use by healthcare professionals in hospital emergency departments nationwide.
Purdue Pharma president and CEO Craig Landau said: “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.”
In February this year, French ad firm Publicis Health and Hikma Pharmaceuticals reached separate settlements totalling $500m to resolve allegations that they contributed to the opioid epidemic in the US.
The allegations included that the advertising firm helped Purdue Pharma, the maker of OxyContin, develop marketing strategies aimed at boosting sales of the prescription opioid painkiller.
