Opiant Pharmaceuticals Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose

Rhea-AI Summary

Opiant Pharmaceuticals (NASDAQ: OPNT) filed the first module of its New Drug Application (NDA) for OPNT003, a nasal nalmefene aimed at treating opioid overdose. This submission follows a previous agreement with the FDA and is part of a rolling submission process, expected to complete by late 2022. The opioid crisis is worsening, with over 80,000 deaths reported in 2021, prompting urgent need for new treatments. OPNT003 has shown promising results in pharmacokinetic studies, demonstrating rapid and sustained effects against opioid overdose.

Positive

• Rapid and sustained action of OPNT003 in reversing opioid overdose.
• NDA submission using the 505(b)(2) pathway allows expedited review.
• Fast Track designation from FDA granted in November 2021.

Negative

• None.

• Company expects to complete submission of the NDA using the 505(b)(2) pathway, as previously agreed upon with the FDA, in the second half of 2022
  

SANTA MONICA, Calif., June 01, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today announced the filing of the first module of its New Drug Application (NDA) for OPNT003, nasal nalmefene, for the treatment of opioid overdose. The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting. As communicated previously, the Company expects to complete the submission of the NDA using the 505(b)(2) pathway in the second half of 2022.

An estimated record 80,816 Americans died of an opioid overdose in 2021, a 17% increase over 2020 and a 62% increase from 2019, according to new data from the U.S. Centers for Disease Control and Prevention (CDC). Deaths involving synthetic opioids, including fentanyl, increased from 36,359 in 2019 and 56,516 in 2020, to an estimated 71,238 in 2021.^1,2 

“The opioid epidemic has evolved with the widening threat from potent synthetic opioids like fentanyl and there is significant evidence indicating that a new treatment option is needed,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “We believe the results from the pharmacokinetic (PK) and pharmacodynamic (PD) studies, in which OPNT003 demonstrated fast, strong, and long-lasting action and a well-tolerated safety profile, support OPNT003 as a potential new treatment option for opioid overdose. We look forward to working with the FDA to complete this rolling submission for OPNT003, nasal nalmefene, and we will provide an update when the NDA is completed.”

Opiant was granted Fast Track designation for OPNT003, nasal nalmefene, in November 2021. The rolling review process allows Opiant to submit completed sections of its NDA for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800029C; and the National Institute on Drug Abuse (NIDA).

About OPNT003, nasal nalmefene
OPNT003, nasal nalmefene, is a high-affinity mu-opioid receptor antagonist that reduces the binding of opioids to this receptor, limiting respiratory depression, the primary cause of overdose injury and death. In a head-to-head pharmacodynamic study, OPNT003 produced a reversal of remifentanil-induced respiratory depression that was nearly twice that produced by NARCAN^® Nasal Spray at the primary endpoint of five minutes. The intrinsic properties of nalmefene, taken together with results from Opiant pharmacokinetic and pharmacodynamic studies, are consistent with the potential of OPNT003 to provide fast, strong, and sustained reversal of opioid overdose.

About Opiant Pharmaceuticals, Inc. 
Opiant Pharmaceuticals, Inc., the company that developed NARCAN^® 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 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, 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.

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

1. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2022.
2. Hedegaard H, Miniño AM, Spencer MR, Warner M. Drug overdose deaths in the United States, 1999–2020. NCHS Data Brief, no 428. Hyattsville, MD: National Center for Health Statistics. 2021.

FAQ

What is OPNT003 and its significance?

OPNT003 is a nasal nalmefene developed by Opiant Pharmaceuticals to treat opioid overdose, addressing the growing opioid crisis.

When did Opiant file its NDA for OPNT003?

Opiant filed the first module of its NDA for OPNT003 on June 1, 2022.

How many overdose deaths were reported in 2021?

In 2021, an estimated 80,816 Americans died of opioid overdose, a 17% increase from 2020.

What designation has OPNT003 received from the FDA?

OPNT003 received Fast Track designation from the FDA to expedite its development and review.

What is the expected completion timeline for the NDA submission?

The NDA submission for OPNT003 is expected to be completed in the second half of 2022.