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FDA Grants Priority Review Designation to OPNT003 Nasal Nalmefene for Opioid Overdose

The PDUFA date has been set for May 22, 2023.

The FDA has accepted for review a New Drug Application (NDA) from Opiant Pharmaceuticals for OPNT003 nasal nalmefene, a product candidate for the treatment of opioid overdose, according to a company press release.1 The NDA has also received a Priority Review designation and a Prescription Drug User Fee Act (PDUFA) date of May 22, 2023.

OPNT003 is a nasal formulation containing high affinity opioid antagonist nalmefene. Results supporting the NDA submission come from 3 studies: a phase 1, open-label, randomized, 2-period, 2-treatment, 2-sequence crossover pharmacokinetic study in 68 healthy volunteers comparing the drug to an intramuscular nalmfene injection (NCT04759768); a phase 1, open-label, randomized, 3-period, 3-treatment, 6-sequence randomized crossover pharmacokinetic study in 24 healthy volunteers comparing a different 3 different dosing options (NCT05219669); and a phase 1, open-label, 2-part pharmacodynamic study comparing the drug to naloxone HCl (Narcan) nasal spray 4 mg (NCT04828005).

Provisional data from the CDC indicate that in the 12-month period ending August 31, 2022, more than 81,000 people died of an opioid overdose, with 90% of those deaths associated with potent synthetic opioids.

“We are delighted to announce that the FDA has accepted Opiant’s NDA for filing and designated it priority review status,” said Roger Crystal, MD, Opiant president and CEO. “We believe the data supporting this NDA indicates that OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis.”

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The development of OPNT003 was supported by an award for up to $10.8 million from the Biomedical Advanced Research and Development Authority and a $7.4 million grant from the National Institute on Drug Abuse.

Reference

  1. Opiant Pharmaceuticals announces FDA acceptance and Priority Review of NDA for OPNT003, nasal nalmefene, for opioid overdose. News release. Opiant Pharmaceuticals. January 19, 2023. Accessed January 20, 2023. https://ir.opiant.com/news-releases/news-release-details/opiant-pharmaceuticals-announces-fda-acceptance-and-priority

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