Opiant Pharmaceuticals Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose

Rhea-AI Summary

Opiant Pharmaceuticals (NASDAQ: OPNT) announced the submission of its rolling New Drug Application (NDA) for OPNT003, a nasal formulation of nalmefene, to the FDA for treating opioid overdose. CEO Roger Crystal expressed optimism that OPNT003 could provide vital support for first responders amid the opioid crisis, which led to over 81,000 deaths in the U.S. in 2022. The NDA is backed by comprehensive pharmacokinetic and pharmacodynamic studies. FDA's decision on the NDA acceptance is anticipated in February 2023. Funding from BARDA and NIDA significantly supported the development process.

Positive

• Submission of NDA for OPNT003 indicates progress in addressing the opioid crisis.
• NDA supported by robust pharmacokinetic and pharmacodynamic studies.
• Funding of up to $10.8 million from BARDA aids in OPNT003 development.

Negative

• None.

SANTA MONICA, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- 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.

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.

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 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, expectation of the FDA’s written decision on filing acceptance of the NDA in February 2023. 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 quarters ended March 31, 2022, June 30, 2022, and September 30, 2022, filed with the Securities and Exchange Commission on March 4, 2022, May 10, 2022, August 11, 2022, and November 14, 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.

For Media and Investor Inquiries:
Ben Atkins, Opiant
(310) 598-5410
batkins@opiant.com

FAQ

What is the significance of Opiant's NDA submission for OPNT003?

The NDA submission for OPNT003 is significant as it aims to provide an important treatment option for opioid overdose, potentially aiding first responders.

When is the FDA decision expected for OPNT003's NDA?

The FDA decision on the NDA acceptance for OPNT003 is expected in February 2023.

How many overdose deaths occurred in the U.S. recently?

Over 81,000 people in the U.S. died from opioid overdoses in the 12 months ending May 31, 2022.

What studies support the NDA submission for OPNT003?

The NDA submission is supported by pharmacokinetic and pharmacodynamic studies comparing OPNT003 to other opioid treatments.