Opiant Pharmaceuticals said that it has received an additional $2.1 million from the US Biomedical Advanced Research and Development Authority (BARDA) to support regulatory activities related to its OPNT003 intranasal nalmefene for the treatment of opioid overdose. BARDA had already provided an additional $2.2 million for OPNT003 earlier this year, and the total amount of BARDA funding for this project is now $10.8 million. The company, which recently initiated a rolling submission of the 505(b)(2) NDA for OPNT003, says that it will use the new funding for preparation and filing of the NDA.
In late 2020, Opiant announced that it was switching the delivery device for OPNT003 from the Bespak Unidose Xtra to Aptar Pharma’s Unit Dose System (UDS) device. Following the switch, Opiant announced positive results from a PK study in July 2021 and, in April 2022, positive results from a PD study of the nalmefene nasal spray. In June 2022, the company said that it was investing €2 million as part of an agreement with Aptar Pharma for expanded manufacturing of the UDS device to support potential demand for OPNT003.
Opiant CEO Roger Crystal commented, “We greatly appreciate BARDA’s support for OPNT003. The worsening opioid overdose crisis, driven particularly by the ever present threat of illicit synthetic opioids, such as fentanyl, underscores the need for overdose reversal treatment options.”
Read the Opiant Pharmaceuticals press release.
