FDA Accepts Filing of Abbreviated New Drug Application and Grants Priority Review for Nalmefene HCI Injection for the Treatment of Known or Suspected Opioid Overdose

STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. (“Purdue”) announced that FDA has accepted and granted priority review to the company’s Abbreviated New Drug Application for the vial dosage form of nalmefene hydrochloride injection.

Injectable nalmefene, an opioid antagonist designed to reverse opioid overdose, may be another treatment option to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids.

Purdue is developing injectable nalmefene in three dosage forms: vial, prefilled syringe and autoinjector. The nalmefene vial and prefilled syringe are generic forms of a previously approved opioid antagonist. The nalmefene autoinjector is being developed for use in the community setting by people without medical training. Use of the nalmefene autoinjector would not replace the need for emergency medical care.

FDA previously granted Competitive Generic Therapy designation for the vial and prefilled syringe and Fast Track designation for the autoinjector.

“Receiving FDA priority review for the nalmefene vial means we can move more quickly to get this opioid overdose reversal medicine into the hands of people who need it if and when approved,” said Craig Landau, MD, CEO and president, Purdue. “Providing this medication is an important part of our commitment, through our proposed Plan of Reorganization, to contribute meaningful solutions to help address the opioid crisis.”

On March 15, 2021, Purdue announced it filed a Plan of Reorganization. As part of this historic plan, Purdue will be dissolved and its assets will be transferred to a new company upon emergence from Chapter 11. The new company, among other things, will oversee the ongoing development and eventual distribution, at or below cost, of:

• Injectable nalmefene.
• A low-cost, over-the-counter naloxone intranasal spray through collaboration with Harm Reduction Therapeutics. Naloxone is also an opioid antagonist.
• A generic version of buprenorphine and naloxone sublingual tablets CIII. In 2020, FDA approved generic buprenorphine and naloxone tablets developed by Rhodes Pharmaceuticals, a subsidiary of Purdue.¹

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that nalmefene injection or Harm Reduction Therapeutics’ OTC naloxone intranasal spray, investigational agents, will successfully complete development or gain FDA approval.

About Purdue Pharma L.P.

Purdue Pharma and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.

The company seeks to achieve a global bankruptcy settlement that would deliver more than $10 billion in value, including 100% of Purdue’s assets and millions of doses of opioid addiction treatment and overdose reversal medicines, to communities across the country to fund programs specifically for abatement of the opioid crisis. The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants.

If Purdue’s settlement is approved, Purdue’s assets will be transferred to a new company. This new company will be governed by new independent board members, and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company will continue serving patients and consumers who rely on its medicines and products, pursuing its pipeline, and introducing medicines that will help save and improve lives.

1. For Buprenorphine and Naloxone Sublingual Tablet full prescribing information, click here; for the medication guide and warnings, click here.