Opiant Pharmaceuticals Announces Completion Of Rolling NDA Submission For OPNT003, Nasal Nalmefene, For Opioid Overdose

Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ:OPNT) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for OPNT003, nasal nalmefene, for the treatment of opioid overdose.

“We are very pleased to submit our NDA for OPNT003,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “We believe the data supporting this NDA indicate OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis in the United States.”

The NDA submission 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).

The FDA decision on NDA filing acceptance is expected in February 2023. 

Over 81,000 people in the United States died of an opioid overdose during the 12 months ended May 31, 2022, according to provisional data from the U.S. Centers for Disease Control and Prevention. About 90% percent – 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.

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 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.