- FDA sets PDUFA date of May 22, 2023
SANTA MONICA, Calif., Jan. 19, 2023 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003, nasal nalmefene, Opiant’s product candidate for the treatment of opioid overdose.
The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing. Priority Review is granted to therapies that the FDA determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.
“We are delighted to announce that the FDA has accepted Opiant’s NDA for OPNT003 for filing and designated it priority review status,” said Roger Crystal, M.D., President and CEO of Opiant. “The acceptance of the OPNT003 NDA filing is an important milestone as it brings us one step closer to the potential approval and U.S. commercial launch of OPNT003. We believe the data supporting this NDA indicates that OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis. We look forward to working with the FDA during the review process.”
Over 81,000 people in the United States died of an opioid overdose during the 12 months ended August 31, 2022, according to provisional data from the U.S. Centers for Disease Control and Prevention. About 90% – approximately 73,000 – of opioid overdose deaths were linked to potent synthetic opioids, driven by illicit fentanyl. For each opioid-induced fatality, it has been estimated there are 6.4-8.4 non-fatal overdoses that can lead to long-term physical and mental disability.
OPNT003 is a nasal formulation containing the high affinity opioid antagonist nalmefene. The 505(b)2 NDA submission for OPNT003 is supported by results from a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection (NCT04759768), a second PK study comparing a single intranasal dose to a single dose in each nostril or two doses in a single nostril (NCT05219669), and a pharmacodynamic study comparing nasal nalmefene to NARCAN® (naloxone HCI) Nasal Spray 4mg in a clinical model of opioid induced respiratory depression (NCT04828005).
An award from the Biomedical Advanced Research and Development Authority (BARDA) for up to $10.8 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, have supported the clinical development and U.S. regulatory submission of OPNT003. The contract with BARDA will potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids as well as a reversal of opioid overdoses in the community.
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This project has been funded in whole or in part with federal funds from HHS/ASPR/BARDA, under contract number HHSO100201800029C.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., 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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