- The Biomedical Advanced Research and Development Authority (BARDA) has awarded an additional approximately $2.1 million to Opiant Pharmaceuticals Inc (NASDAQ: OPNT) to support OPNT003, nasal nalmefene, for opioid overdose.
- The increase in funding is primarily directed toward preparing and filing a marketing application for OPNT003 to the FDA.
- OPNT003 is a nasal formulation containing the high-affinity opioid antagonist nalmefene.
- Opiant has initiated the rolling submission of a marketing application to the FDA for OPNT003 using the 505(b)(2) pathway and intends to complete the filing in 2H 2022.
- Earlier awards from BARDA for $8.7 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, have also supported the clinical development and U.S. regulatory submission of OPNT003.
- The contract with BARDA will also potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids and reversal of opioid overdoses in the community.
- Price Action: OPNT shares closed 16% lower at $10.00 during after-hours trading on Monday.
Read at Benzinga