Last Updated on August 8, 2022 by GlobeNewsWire
SANTA MONICA, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded an additional approximately $2.1 million to support OPNT003, nasal nalmefene, for the treatment of opioid overdose. The increase in funding is primarily directed towards the preparation and filing of a New Drug Application (NDA) for OPNT003 to the U.S. Food and Drug Administration (FDA).
“We greatly appreciate BARDA’s support for OPNT003,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “The worsening opioid overdose crisis, driven particularly by the ever present threat of illicit synthetic opioids, such as fentanyl, underscores the need for overdose reversal treatment options.”
A record number of people in the United States (U.S.), over 80,000, died of an opioid overdose during the 12 months ending February 2022, according to provisional data from the U.S. Centers for Disease Control and Prevention (CDC). Eighty-nine percent – nearly 73,000 – of opioid overdose deaths were linked to synthetic opioids, driven by fentanyl.1 For each opioid-induced fatality, there are between 6.4-8.4 non-fatal overdoses which can lead to long-term physical and mental disability.2
OPNT003, a nasal formulation containing the high affinity opioid antagonist, nalmefene, was studied in three clinical trials: a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection, a second PK study comparing a single intranasal dose to a single dose in each nostril or two doses in a single nostril, and a pharmacodynamic (PD) study comparing nasal nalmefene to nasal naloxone in reversing opioid-induced respiratory depression. The PK studies demonstrated rapid absorption and higher plasma concentrations versus intramuscular injection.3,4 In the PD study, OPNT003 met the primary endpoint of non-inferiority to nasal naloxone, producing a reversal in remifentanil-induced respiratory depression that was nearly twice that produced by nasal naloxone at five minutes.5 Opiant has initiated rolling submission of an NDA to the FDA for OPNT003 using the 505(b)(2) pathway and intends to complete the filing in the second half of 2022. OPNT003 was granted Fast Track Designation in November 2021.
Earlier awards from BARDA for $8.7 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, have also supported the clinical development and U.S. regulatory submission of OPNT003. The contract with BARDA will also potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids as well as reversal of opioid overdoses in the community.
BARDA is part of the Administration for Strategic 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 Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800029C.
About Opiant Pharmaceuticals, Inc. Opiant Pharmaceuticals, Inc., the company that developed NARCAN(R) Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.
Forward-Looking StatementsThis 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 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, completion of the NDA filing in the second half of 2022. 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, 2021 and our Form 10-Q for the quarter ended March 31,2022, filed with the Securities and Exchange Commission on March 4, 2022 and May 10, 2022, respectively, 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.
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1. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2022.2. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacology & Therapeutics. 2022.3. ClinicalTrials.gov Identifier: NCT047597684. ClinicalTrials.gov Identifier: NCT052196695. ClinicalTrials.gov Identifier: NCT04828005