According to Opiant Pharmaceuticals, the FDA has accepted the company’s NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose for priority review and has set a PDUFA date of May 22, 2023. In October 2022, Opiant announced that it had completed its rolling submission of the NDA for OPNT003.
The company has received funding from the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute on Drug Abuse for development of OPNT003. The intranasal nalmefene is delivered via Aptar Pharma’s Unit Dose System (UDS) device, and Opiant has committed €2 million to expand manufacturing of that device.
Opiant President and CEO Roger Crystal said, “We are delighted to announce that the FDA has accepted Opiant’s NDA for OPNT003 for filing and designated it priority review status. The acceptance of the OPNT003 NDA filing is an important milestone as it brings us one step closer to the potential approval and US 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.”
Read the Opiant Pharmaceuticals press release.
