Specialty pharmaceuticals maker Opiant (NASDAQ:OPNT) has received a priority review for its New Drug Application (NDA) for OPNT003 from the U.S. Food and Drug Administration. The candidate is targeted for the treatment of opioid overdose and the PDUFA (Prescription Drug User Fee Act) date is now set for May 22.
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The development now brings down the review time to six months from the earlier 10 months for OPNT003. In the U.S. over 81,000 deaths were caused by an opioid overdose in the year ended August 31, 2022, and about 73,000 of these deaths were due to potent synthetic opioids.
OPNT003 is a nasal formulation and its development has been supported by grants from the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute on Drug Abuse.
Opiant shares have surged nearly 98% over the past six months and Wall Street currently has a Hold consensus rating on the stock alongside an average price target of $21.50.
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