OPNT - Opiant gets FDA fast track status for OPNT003 for treatment of opioid overdose

The U.S. FDA has granted fast track designation to Opiant Pharmaceuticals' (NASDAQ:OPNT) OPNT003, nasal nalmefene, its investigational treatment for opioid overdose. Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a potential rolling submission of the marketing application. In July, the company reported positive results from a confirmatory pharmacokinetic (“PK”) study comparing OPNT003 to intramuscular nalmefene injection.

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Opiant gets FDA fast track status for OPNT003 for treatment of opioid overdose