SANTA MONICA, Calif., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") 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.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission on March 21, 2019, including under the caption titled "Risk Factors." These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
Investor Relations Contact:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
Daniel@lifesciadvisors.com
(617) 430-7576
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