Opiant Pharmaceuticals Announces Additional $2.2 million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development Program

Rhea-AI Summary

Opiant Pharmaceuticals (NASDAQ: OPNT) announced a $2.2 million funding increase from BARDA to support OPNT003, a nasal nalmefene for opioid overdose treatment. This funding will aid clinical studies necessary for FDA submission. OPNT003 has shown promising results in pharmacodynamic studies against nasal naloxone. The project aligns with Opiant's mission to address the opioid crisis, exacerbated by synthetic opioids like fentanyl. Earlier BARDA awards totaling $8.1 million and a $7.4 million grant further support this initiative.

Positive

• Additional $2.2 million funding from BARDA enhances OPNT003's development.
• OPNT003 demonstrates superior absorption and prolonged effects compared to intramuscular nalmefene.
• Fast Track Designation from FDA accelerates the approval process.

Negative

• None.

SANTA MONICA, Calif., Jan. 24, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (“BARDA”) for an additional commitment of up to $2.2 million to support OPNT003, nasal nalmefene, for opioid overdose. The increase in funding is primarily directed toward the costs of Opiant’s clinical studies to support its submission of OPNT003 to the Food and Drug Administration (“FDA”).

Opiant is currently completing a non-inferiority pharmacodynamic (“PD”) study comparing nasal nalmefene with nasal naloxone in reversing respiratory depression produced by remifentanil, a synthetic opioid. In a confirmatory pharmacokinetic (“PK”) study, conducted last year, OPNT003 exhibited fast absorption and high plasma concentrations that surpassed intramuscular nalmefene, as well as a comparable long duration. These are attributes that support OPNT003 as a potential major advance in opioid overdose reversal. OPNT003 is being developed using a 505(b)(2) pathway, with PK and PD studies supporting NDA submission. In November 2021, the FDA granted OPNT003 Fast Track Designation.

“A national crisis of opioid overdose requires innovation to save lives, and we believe OPNT003, nasal nalmefene, has the potential to offer an important new overdose treatment in the community,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “BARDA has been an outstanding partner for OPNT003, and we are excited to advance closer to New Drug Application (“NDA”) submission this year with their support.”

Opioid overdose is a significant public health crisis that has been exacerbated by the increased availability and abuse of synthetic opioids, such as fentanyl. In a 12-month period that ended in June 2021, over 76,000 people in the U.S. died from an opioid overdose¹.

Earlier awards from BARDA for up to $8.1 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, also support 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 reverse opioid overdoses in the community.

BARDA is part of the Office of the Assistant Secretary for 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; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800029C.

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 or our industry's 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, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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, 2019, filed with the Securities and Exchange Commission on March 4, 2020, 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

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¹ Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2022.

FAQ

What is the significance of the $2.2 million funding for Opiant Pharmaceuticals (OPNT)?

The funding from BARDA supports the development of OPNT003, enhancing Opiant's efforts to submit for FDA approval.

How does OPNT003 compare to nasal naloxone?

OPNT003 has shown faster absorption and higher plasma concentrations than nasal naloxone, making it a potentially more effective overdose treatment.

What is the current status of OPNT003's FDA submission?

Opiant is progressing towards New Drug Application (NDA) submission with ongoing clinical studies supported by BARDA.

How many people died from opioid overdoses in the last year?

Over 76,000 people in the U.S. died from opioid overdoses in a year ending June 2021.

What previous funding has Opiant received for OPNT003?

Opiant previously received up to $8.1 million from BARDA and a $7.4 million grant from the National Institute on Drug Abuse.