The FDA has approved Indivior’s Opvee nalmefene nasal spray (OPNT003) for the treatment of opioid overdose, the company announced. Indivior recently acquired the intranasal nalmefene product as part of its acquisition of Opiant Pharmaceuticals. The company said that it expects to launch the nasal spray by the end of 2023.
Opiant announced in June 2022 that it had initiated a rolling submission of the 505(b)(2) NDA for OPNT003 and said that it completed the submission in November 2022. The FDA accepted the application for review in January 2022. Development of OPNT003 was funded largely by a contract from the Biomedical Advanced Research and Development Authority (BARDA) worth up to $10.8 million and a $7.4 million grant from the National Institute on Drug Abuse.
Initially, Opiant developed OPNT003 for delivery via a Bespak device, but the company switched to switched to Aptar Pharma’s Unit Dose System (UDS) nasal device in 2020. In June 2022, Opiant announced that it would invest €2 million for additional production capacity of the UDS device in anticipation of potential commercial demand.
Indivior CEO Mark Crossley commented, “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl. Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available to those who need it most to help save lives.”
Read the Indivior press release.
