Ensysce Biosciences Awarded $5.3 Million in Continued NIDA Support to Advance Breakthrough Opioid Overdose Protection

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) has received a $5.3 million grant from NIDA as part of a $15 million, three-year funding commitment to advance PF614-MPAR, their breakthrough opioid therapy. This FDA-designated Breakthrough Therapy combines TAAP and MPAR technologies to provide effective pain relief while incorporating built-in overdose protection. The funding, which began June 1, 2025, will support final drug formulation optimization and clinical evaluation as the company moves toward commercialization. Initial clinical studies have validated the drug's overdose prevention capabilities, and Ensysce plans to engage with the FDA to discuss development plans based on current data.

Positive

• Received $5.3 million grant from NIDA as part of a larger $15 million commitment
• FDA Breakthrough Therapy designation for PF614-MPAR
• Successful clinical validation of overdose prevention capabilities
• Moving towards commercialization phase with optimized drug formulation

Negative

• Still in clinical-stage development with no immediate revenue generation
• Requires further clinical evaluation and FDA approval before commercialization

Insights

Pharmaceutical R&D Expert

Ensysce receives continued NIDA funding for its breakthrough overdose-resistant opioid, accelerating commercialization of a potentially transformative pain management solution.

Ensysce Biosciences has secured the second $5.3 million installment of a $15 million NIDA grant to advance PF614-MPAR, their novel opioid designed with built-in overdose protection. This funding represents a significant validation of their technology from a major federal institution.

The company's approach combines two proprietary technologies: TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance), creating a unique mechanism that maintains pain relief efficacy while limiting overdose potential. Most critically, the FDA has granted this candidate Breakthrough Therapy designation - a designation reserved for drugs treating serious conditions with preliminary evidence indicating substantial improvement over available therapies.

The timing is notable as the development now enters a decisive phase focused on formulation finalization and preparation for commercialization. Previous clinical studies have already validated the drug's overdose protection capabilities, confirming their technological approach. The company plans to engage with FDA in the coming months to align on the complete development pathway.

This continued funding significantly derisks Ensysce's development program at a crucial juncture. With over 100,000% overdose deaths annually in the US, regulatory authorities are actively seeking safer alternatives to traditional opioids. PF614-MPAR's unique engineering addresses this critical need while potentially preserving the pain management benefits that make opioids necessary for certain patient populations.

~ PF614-MPAR Moving to Next Stage of Development, Finalizing Drug Formulation ~

~ Funds Accelerate Path Towards Commercialization ~

SAN DIEGO, CA / ACCESS Newswire / June 4, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced it was awarded the second $5.3 million installment of a $15 million, three-year grant from the National Institute on Drug Abuse (NIDA)¹. This continued support will accelerate the clinical and non-clinical development of PF614-MPAR, a next-generation opioid designed to offer powerful pain relief while dramatically reducing the risk of overdose.

PF614-MPAR, which has earned the FDA's prestigious Breakthrough Therapy designation, is uniquely engineered using Ensysce's proprietary TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) technologies. These platforms enable PF614-MPAR to maintain therapeutic efficacy while offering built-in overdose protection - even when doses exceed prescribed amounts, whether accidentally or intentionally.

The first year of NIDA funding, together with outside capital raised, enabled a series of promising clinical studies that validated PF614-MPAR's ability to prevent overdose. This next phase of funding which began on June 1, 2025, will focus on optimizing the final drug formulation, undertaking further clinical evaluation while preparing to move to commercialization. Ensysce plans to engage with the FDA in the coming months to align on full development plans based on the robust data generated to date.

Dr. Lynn Kirkpatrick, CEO of Ensysce, commented, "Our initial clinical results confirm what we set out to achieve - a safer opioid that can offer what we believe is real protection in overdose scenarios. PF614-MPAR is the only opioid product to receive FDA Breakthrough Therapy status, a testament to its potential impact. NIDA's continued support is a powerful endorsement of our mission to deliver innovative, life-saving solutions for pain management. With these additional funds, we're accelerating toward commercialization and look forward to working closely with the FDA on our next steps."

¹The research is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UO1DA059791.

About Ensysce Biosciences

Ensysce Biosciences is a clinical stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP^TM) and Multi-Pill Abuse Resistance (MPAR^®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com.

Forward-Looking Statements

Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.

Ensysce Biosciences Company Contact:
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196

Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us

SOURCE: Ensysce Biosciences

View the original press release on ACCESS Newswire

FAQ

What is the significance of ENSC receiving $5.3 million from NIDA?

The $5.3 million grant is the second installment of a $15 million, three-year NIDA grant, supporting the development of PF614-MPAR, their breakthrough opioid therapy with built-in overdose protection.

What makes Ensysce's PF614-MPAR unique in the opioid market?

PF614-MPAR combines proprietary TAAP and MPAR technologies to provide pain relief while offering built-in overdose protection, making it the only opioid product to receive FDA Breakthrough Therapy status.

What is the current development stage of ENSC's PF614-MPAR?

PF614-MPAR has completed initial clinical studies validating its overdose prevention capabilities and is now moving to optimize final drug formulation and further clinical evaluation before commercialization.

When did Ensysce Biosciences receive the NIDA funding for PF614-MPAR?

The second phase of NIDA funding began on June 1, 2025, following successful completion of initial clinical studies.

What are the next steps for Ensysce Biosciences' PF614-MPAR development?

Ensysce plans to engage with the FDA to discuss development plans, optimize final drug formulation, and conduct further clinical evaluation while preparing for commercialization.