According to Opiant Pharmaceuticals, the company’s contract with the Biomedical Advanced Research and Development Authority (BARDA) has been amended to provide an additional $2.2 million to support activities related to a 505(b)(2) NDA submission for OPNT003 nalmefene nasal spray for the treatment of opioid overdose.
In July 2021, Opiant announced positive results from a PK study of OPNT003, and the company says that it is currently finishing up a PD study evaluating OPNT003 against intranasal naloxone for opioid reversal.
In December 2020, Opiant received $3.5 million in funding from the BARDA contract, which it said it was using in part to reformulate the nasal spray for delivery via the Aptar Unit Dose System (UDS) device after terminating a previous agreement with Bespak for the use of the Unidose Xtra device for delivery of OPNT003. In total, the company has previously received $8.1 million from BARDA and $7.4 million from the National Institute on Drug Abuse (NIDA) for OPNT003.
Opiant President and CEO Roger Crystal commented, “A national crisis of opioid overdose requires innovation to save lives, and we believe OPNT003, nasal nalmefene, has the potential to offer an important new overdose treatment in the community. BARDA has been an outstanding partner for OPNT003, and we are excited to advance closer to New Drug Application (“NDA”) submission this year with their support.”
Read the Opiant Pharmaceuticals press release.
