Opiant Pharmaceuticals Announces Additional $2.1 Million Funding Under BARDA Contract for OPNT003, Nasal Nalmefene
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)() 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.
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1. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2022.