The Biomedical Advanced Research and Development Authority (BARDA) will provide additional funding of up to $2.2 million to support Opiant Pharmaceuticals Inc's (NASDAQ:OPNT) OPNT003, nasal nalmefene, for opioid overdose.
- The increase in funding is primarily directed toward the costs of Opiant's clinical studies to support its submission of OPNT003 to the FDA.
- The Company is currently completing a non-inferiority pharmacodynamic study comparing nasal nalmefene with nasal naloxone in reversing respiratory depression produced by remifentanil, a synthetic opioid.
- Also See: Opiant Pharma Starts Dosing In OPNT002 Mid-Stage Study For Alcohol Use Disorder.
- In a confirmatory pharmacokinetic study conducted last year, OPNT003 exhibited fast absorption and high plasma concentrations that surpassed intramuscular nalmefene, as well as a comparable long duration.
- Earlier awards from BARDA for up to $8.1 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, also support the clinical development and U.S. regulatory submission of OPNT003.
- In November 2021, the FDA granted OPNT003 Fast Track Designation.
- Price Action: OPNT shares closed at $26.09 on Monday.
