Opiant announces FDA acceptance, priority review of NDA of OPNT003

Opiant Pharmaceuticals 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. "We are delighted to announce that the FDA has accepted Opiant’s NDA for OPNT003 for filing and designated it priority review status," said Roger Crystal, M.D., President and CEO of Opiant. "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. We believe the data supporting this NDA indicates that OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis. We look forward to working with the FDA during the review process."