Opiant: FDA Acceptance and Priority Review of NDA for Opioid Overdose Treatment

 Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003, nasal nalmefene, Opiant’s product candidate for the treatment of opioid overdose.

The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing. Priority Review is granted to therapies that the FDA determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.

https://finance.yahoo.com/news/opiant-pharmaceuticals-announces-fda-acceptance-210500729.html