FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose
19 January 2023 - - The US FDA has accepted and granted priority review to US-based Purdue Pharma L.P.'s Abbreviated New Drug Application for Nalmefene Hydrochloride injection, 2 mg/2 mL (1mg/1mL) Prefilled Syringe, the company said.

Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.

Priority review is often granted to new therapies that fulfill an unmet medical need.

The company is investing in nalmefene development efforts to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids.

Earlier last year, Purdue received FDA approval for a vial dosage form of injectable nalmefene. In addition, FDA previously granted Competitive Generic Therapy designation for the prefilled syringe and the nalmefene hydrochloride injection vial.

If approved, the nalmefene prefilled syringe dosage form will be distributed at no profit and is intended for use by paramedics with advanced medical training, emergency department physicians, physician assistants, nurse practitioners, and nurses.

Purdue's nalmefene injection vial is currently being distributed for no profit.

Both nalmefene vial and prefilled syringe are generic forms of a previously approved opioid antagonist. Purdue is also developing an autoinjector form of nalmefene for potential use in the community setting by people without medical training.