Opiant Pharma Advances OPNT003 PK Study With First Patient Dosing

Opiant Pharmaceuticals Inc (NASDAQ: OPNT) doses the first patient in a confirmatory pharmacokinetic (PK) study evaluating OPNT003 (nasal nalmefene) for opioid overdose treatment. Results from the study are anticipated in June 2021.
The open-label, randomized, crossover study will enroll 68 healthy volunteers and determine the pharmacokinetic profile of intranasally administered nalmefene compared to intramuscularly administered nalmefene.
A separate pharmacodynamic study in healthy volunteers is also planned for later this year.
The development of OPNT003 is supported by grants from the National Institute on Drug Abuse, part of the NIH, and the Biological Advance Research and Development Agency.
Opiant intends to pursue a 505(b)(2) regulatory pathway (to accelerate the development of promising new medications by allowing the use of data based on previously approved drugs) for OPNT003 with the FDA by the end of 2021.
Price Action: OPNT shares jumped 7.33% at $14.45 during market trading hours on the last check Tuesday.