SANTA MONICA, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced an additional commitment of up to $3.5 million from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance the clinical development of OPNT003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million.
“We thank BARDA for their ongoing support of OPNT003, nasal nalmefene,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “We believe OPNT003, nasal nalmefene, has the potential to be a best-in-class rescue agent for preventing opioid overdose deaths, particularly from synthetic opioids like fentanyl. We remain on track to file a New Drug Application with the U.S. Food and Drug Administration by the end of 2021.”
An earlier award from BARDA for up to $4.6 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse (“NIDA”), also supports the clinical development and U.S. regulatory submission of OPNT003. The additional BARDA support will fund both a planned pharmacodynamic study in healthy volunteers and development work associated with the use of Aptar Pharma’s Unit Dose System.
Opioid overdose is a significant public health crisis that has been exacerbated by the increased availability and abuse of synthetic opioids, such as fentanyl. Fentanyl is 50-fold more potent than heroin, far easier and less expensive to produce, and has a significantly longer half-life. Fentanyl and related synthetic opioids were linked to more than 75% of the nearly 51,000 opioid overdose deaths in 2019 in the U.S. The contract with BARDA allows for development of OPNT003 as a medical countermeasure in a chemical attack using synthetic opioids.
This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800029C.
OPNT003, nasal nalmefene, is in development as a potent, rapid-onset, long-acting opioid antagonist for the treatment of opioid overdose. OPNT003 is designed as a rescue medication that could be especially useful in treating overdose by high-potency synthetic opioids, such as fentanyl. OPNT003 is also being considered as an antidote in a civilian mass casualty event. The development of OPNT003 is supported by grants from the NIH and BARDA. Opiant intends to pursue a 505(b)(2) regulatory pathway for OPNT003.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.
For more information visit: www.opiant.com.
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