OPNT - Opiant wins FDA priority review for opioid overdose therapy

• Specialty pharma company Opiant Pharmaceuticals ( NASDAQ: OPNT ) announced that the FDA accepted its New Drug Application (NDA) for nasal opioid overdose therapy OPNT003, granting it the agency’s Priority Review designation.
• The FDA has issued May 22, 2023, as the target action date for its decision speeding up the review period from ten months to six months.
• A nasal drug comprising the high-affinity opioid antagonist nalmefene, OPNT003 has undergone several pharmacokinetic (PK) and pharmacodynamic studies, the results of which have backed the company’s NDA.
• “The acceptance of the OPNT003 NDA filing is an important milestone as it brings us one step closer to the potential approval and U.S. commercial launch of OPNT003,” said Opiant’s ( OPNT ) Chief Executive Roger Crystal.
• Read: Seeking Alpha contributor Bram de Haas comments on the decision by small-cap pharma Indivior PLC ( OTCPK:INVVY ) to acquire Opiant ( OPNT ) for nearly $145M in cash.

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