FDA grants priority review for prefilled nalmefene syringe for overdose treatment

The FDA has accepted and granted priority review to Purdue Pharma’s abbreviated new drug application for the opioid antagonist nalmefene hydrochloride injection 2 mg/2 mL prefilled syringes, the company announced in a press release.

According to the release, priority review is often granted for new therapies that fulfill an unmet medical need. Purdue is investing in nalmefene development efforts to help address the continued opioid epidemic.

Nalmefene is indicated for reversing the effects of natural and synthetic opioids and for managing opioid overdose, the company stated.

In February 2022, the FDA approved the vial dosage form of injectable nalmefene. In addition, the FDA also granted competitive generic therapy designation for the prefilled syringe and the nalmefene hydrochloride injection vial.

“Nalmefene is an important treatment option to help abate the opioid crisis, which is being fueled by the increasing prevalence of illicitly manufactured synthetic opioids,” Purdue Pharma President and CEO Craig Landau, MD, said in the release. “Multiple interventions are required. We are committed to supporting a multi-faceted approach to abating the opioid crisis and look forward to FDA’s response to our second dosage form for nalmefene.”

If the FDA approves the prefilled syringe doses, Purdue will distribute them at no profit, for the intended purpose of use by paramedics, physicians, physician assistants and nurses, the release stated.

Purdue also said it is currently developing an autoinjector form of nalmefene for potential use in the community setting by people without medical training.