As the White House attempts to expand overdose treatment, Ensysce is planning to provide pain relief with overdose protection.

~ Ensysce Biosciences on track to deliver the first overdose protection product ~

On May 17, 2023 the White House announced plans to expand care for opioid overdoses, a sign of the scale of the opioid crisis. The CEO of Ensysce has a bold plan to tackle this problem head on, by introducing the first ever opioid with overdose protection.

Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC) a clinical-stage company applying transformative chemistry to improve prescription drug safety, just delivered ground-breaking data for their overdose protection program. Dr. Lynn Kirkpatrick discussed a new class of products, MPAR^TM, which Ensysce believes have the potential to fundamentally change medicine and reduce opioid abuse and overdose.

Drug overdose deaths spiked after the start of the COVID-19 pandemic and during 2020 and 2021 claimed nearly 200,000 lives. (Ref Wonder). Wednesday’s announcement stated that opioid abuse has plagued the country for more than two decades and killed more than a half million Americans, according to Federal data. The solution to make naloxone, which reverses or reduces the effects of opioids, more accessible is a good step to save lives but Ensysce has another approach: to provide safer, less abusable opioids with built in overdose protection, since opioids are still needed to treat severe pain.

Dr. Kirkpatrick explains “The basis of our strategy is to attack the problem before it begins, using high tech chemistry. We have designed opioid products which can be “switched on and off” to give pain relief but reduce abuse and overdose. We believe this technology can be applied to many drug classes, and we are developing a novel opioid first.”

PF614-MPAR™ is the first drug in the Ensysce pipeline which can limit opioid exposure when too many pills are swallowed. The recently announced Phase 1 study data showed that a 25 mg dose of PF614-MPAR™, delivered oxycodone as designed for a prescribed dose of up to 2 capsules but when more capsules were consumed simultaneously the amount of opioid released and absorbed into the circulation diminished significantly.

Ensysce believes that safer opioids have a place in the treatment of pain. The publicity surrounding the opioid crisis continues to create issues for people struggling to get access to adequate pain medication.

Dr. Kirkpatrick is optimistic about the future, “With over 200 individuals still dying daily, we are losing too many people to overdose. My team is committed to delivering true innovations for pain management, with what we believe are safer alternatives that can protect from overdose and save many lives ”.

About Ensysce Biosciences

Ensysce Biosciences is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging TAAP^TM and MPAR™, the Company is in the process of developing a unique, tamper-proof treatment option for pain that minimizes the risk of both drug abuse and overdoses. 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. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.

Definitions/ References

‘TAAP’: trypsin-activated abuse protection – designed to protect against prescription drug abuse.

‘MPAR’: multi-pill abuse resistance – designed to protect against abuse and accidental overdose.

Reference 1 = https://nationalpain.org/fast-facts-about-pain

Reference 2 = https://www.uspharmacist.com/article/consequences-of-highimpact-chronic-pain

Reference 3 = https://www.oatext.com/the-risk-of-suicide-in-chronic-pain-patients.php

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:
MZ Group North America
Shannon Devine
203-741-8811
ENSC@mzgroup.us