FDA Prioritizes Review of Nalmefene Prefilled Syringe for Opioid Overdose

The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.

The device will be preloaded with a 2 mg/2 mL dose to provide faster administration than the current method of measuring the drug from a vial. Purdue received FDA approval for a vial dosage form of the injectable opioid antagonist in 2022.

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

Purdue is also developing an autoinjector form for potential use by community members without medical training.