News Release Details
Opiant Pharmaceuticals Announces Additional $2.2 million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development Program
Opiant is currently completing a non-inferiority pharmacodynamic (“PD”) study comparing nasal nalmefene with nasal naloxone in reversing respiratory depression produced by remifentanil, a synthetic opioid. In a confirmatory pharmacokinetic (“PK”) study, conducted last year, OPNT003 exhibited fast absorption and high plasma concentrations that surpassed intramuscular nalmefene, as well as a comparable long duration. These are attributes that support OPNT003 as a potential major advance in opioid overdose reversal. OPNT003 is being developed using a 505(b)(2) pathway, with PK and PD studies supporting NDA submission. In
“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,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “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.”
Opioid overdose is a significant public health crisis that has been exacerbated by the increased availability and abuse of synthetic opioids, such as fentanyl. In a 12-month period that ended in
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
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with federal funds from the
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1 Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts.
Source: Opiant Pharmaceuticals, Inc.