Opiant intends to pursue a 505(b)(2) development path for OPNT003 and anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in the fourth quarter 2020.
SANTA MONICA, Calif., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today announced that it has been awarded the second tranche of approximately $2.4 million from the total contract award of up to a maximum of approximately $4.6 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate Opiant’s development of OPNT003, nasal nalmefene, a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose.
Opiant intends to pursue a 505(b)(2) development path for OPNT003 and anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in the fourth quarter 2020.
“The award of this second tranche aligns with the progress we have achieved to date around the development of OPNT003,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “We will use these funds in 2020 to further advance our OPNT003 development program. Our contract with BARDA, which is aimed at accelerating the development of OPNT003 as a medical countermeasure in the event of a fentanyl chemical attack, further validates the potential of nasal nalmefene to be a vital therapy in the treatment of opioid overdose.”
To date, Opiant has been awarded approximately $3.0 million of the maximum BARDA contract award of $4.6 million. The balance will be funded next year, subject to satisfactory project progress, funds availability and certain other conditions.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing medicines for addictions and drug overdose. NIDA, a division of the National Institutes of Health, describes addictive disorders as chronic relapsing brain diseases that burden society at both the individual and community levels. Opiant’s first drug overdose product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by its licensee, Adapt Pharmaceuticals, now owned by Emergent BioSolutions Inc. For more information visit: www.opiant.com.
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Dan Ferry
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LifeSci Advisors, LLC
Daniel@lifesciadvisors.com
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