Ensysce Biosciences Selected to Present at American Association of Pain Medicine Annual Conference

Rhea-AI Summary

Ensysce Biosciences, Inc. (NASDAQ:ENSC) announced that their PF614-MPAR has been recognized as a potential medical breakthrough and was selected to present one of the top 12 best Flash Talks at the 2024 American Association of Pain Medicine (AAPM) Meeting. The company's novel PF614-MPAR is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by 'shutting down' opioid release if too much active drug is consumed. PF614-MPAR was granted Breakthrough Therapy designation by the FDA, recognizing its innovative approach to preventing prescription opioid overdoses. Ensysce's CEO and Chief Medical Officer expressed their enthusiasm and confidence in the potential of PF614-MPAR and its ability to disrupt the opioid market while mitigating the risk of overdose.

Insights

Pharmaceutical Analyst

The FDA's Breakthrough Therapy designation for Ensysce Biosciences' PF614-MPAR is a critical milestone that can significantly expedite the drug's development and review process. This designation is reserved for drugs that demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The potential of PF614-MPAR to mitigate overdose risks in opioid treatment addresses a pressing public health concern, given the ongoing opioid epidemic. If successful, this could lead to a paradigm shift in pain management, offering effective relief while curbing abuse and accidental overdoses.

From an investment perspective, this development could position Ensysce Biosciences favorably in the opioid market. The company's stock valuation could see an uptick as the market anticipates the entry of a safer alternative to traditional opioids. However, investors should consider the risks inherent in clinical development, including potential regulatory hurdles and the outcomes of Phase 3 trials. The market for pain medication is highly competitive and the success of PF614-MPAR hinges not only on clinical efficacy and safety but also on market acceptance and the ability to secure insurance coverage and favorable reimbursement rates.

Medical Research Analyst

The recognition of Ensysce Biosciences' PF614-MPAR at the AAPM Meeting underscores its innovative approach to pain management. The Trypsin-Activated Abuse Deterrent (TAAP) technology is a novel mechanism designed to prevent the release of high doses of opioids, thereby reducing the risk of overdose. This dual-action approach, offering both abuse deterrence and overdose protection, could be a significant advancement in the field of pain medicine.

For healthcare providers and patients, the introduction of PF614-MPAR could lead to a shift in prescribing practices, favoring opioids with built-in safety features. The long-term impact on public health could be substantial, potentially reducing the incidence of opioid-related morbidity and mortality. The clinical development and eventual market introduction of such a drug require careful monitoring, as the effectiveness of the TAAP technology in real-world settings will be a key determinant of its success.

Market Research Analyst

The potential market impact of Ensysce Biosciences' PF614-MPAR extends beyond its clinical benefits. The opioid crisis has led to increased regulatory scrutiny and demand for safer pain management options. A successful introduction of PF614-MPAR could disrupt the current opioid market by setting new standards for safety. This could force competitors to innovate or risk losing market share, leading to broader industry changes.

It's important to analyze the addressable market size for this new class of opioids and identify key demographics that could benefit from PF614-MPAR. Market penetration will depend on the drug's efficacy, safety profile, cost and how it is received by both the medical community and patients. Additionally, payer acceptance and the drug's inclusion in treatment guidelines will be crucial for widespread adoption. Stakeholders should monitor Ensysce's progress closely as the company moves towards Phase 3 trials and eventual commercialization.

~ PF614-MPAR recognized as potential medical breakthrough ~

SAN DIEGO, CA / ACCESSWIRE / February 6, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced they have been selected to present one of the top 12 best Flash Talks in the Trailblazer Session at the 2024 American Association of Pain Medicine (AAPM) Meeting on March 9^th. Dr. William Schmidt, Chief Medical Officer of Ensysce, will present "Preventing Prescription Drug Overdoses: Clinical development of Trypsin-Activated Abuse Deterrent (TAAP) Opioids with Overdose Protection".

The American Association of Pain Medicine is a leading organization in the country for pain experts and practitioners, with the mission to advance education, advocacy and research to improve the quality of life for people in pain. The flash talk designation is awarded to a small number of programs that convey novel information with great potential and are of interest to pain specialists. Ensysce's novel PF614-MPAR is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by ‘shutting down' opioid release if too much active drug is consumed. PF614-MPAR could herald a new class of treatment for the most severe forms of pain and could save lives if approved, as each capsule contains built-in protection against both abuse and overdose which plague traditional opioids. In late January, the Company's PF614-MPAR was granted Breakthrough Therapy designation by the FDA, recognizing its innovative approach to preventing prescription opioid overdoses.

Dr. Lynn Kirkpatrick, PhD, Chief Executive Officer of Ensysce Biosciences, commented, "We are delighted to be recognized by AAPM, an organization which we hold in very high regard. We believe PF614-MPAR is a true game-changer but it's always encouraging to learn that leading external experts share our enthusiasm. Following our constructive End of Phase 2 meeting with the FDA informing the strategic design of the upcoming Phase 3 studies, and recent Breakthrough Therapy Designation of PF614-MPAR, we are encouraged by the AAPM's interest as we accelerate the development of the ‘Next Generation' opioid to treat severe pain layered with overdose protective properties."

Dr. William Schmidt, Chief Medical Officer, added, "Recognition by the AAPM of our unique PF614-MPAR platform is particularly notable, and to be selected as one of the top twelve best topics in the flash talk category is highly encouraging. I look forward to presenting our extremely innovative data to experts and professionals in the pain field. As PF614, our lead opioid with novel abuse protection, continues to move toward approval, we believe the second layer of safety from our MPAR technology will disrupt the opioid market and mitigate the risk of overdose."

About Ensysce Biosciences

Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. 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. 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.

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 Inc.

View the original press release on accesswire.com

FAQ

What is the significance of PF614-MPAR being recognized as a potential medical breakthrough?

PF614-MPAR being recognized as a potential medical breakthrough signifies its innovative approach to preventing prescription opioid overdoses, as well as its potential to disrupt the opioid market while mitigating the risk of overdose.

What is the Breakthrough Therapy designation granted by the FDA for PF614-MPAR?

The Breakthrough Therapy designation granted by the FDA for PF614-MPAR recognizes its innovative approach to preventing prescription opioid overdoses, indicating its potential to address unmet medical needs.

What is the purpose of the 2024 American Association of Pain Medicine (AAPM) Meeting?

The 2024 AAPM Meeting aims to advance education, advocacy, and research to improve the quality of life for people in pain, and recognizes programs with novel information of interest to pain specialists.

What is the mission of the American Association of Pain Medicine?

The mission of the American Association of Pain Medicine is to advance education, advocacy, and research to improve the quality of life for people in pain.

What is the potential impact of PF614-MPAR on the opioid market?

PF614-MPAR has the potential to disrupt the opioid market by providing optimal pain relief at prescribed doses while limiting accidental or intentional overdose, thereby mitigating the risk of overdose.

What is the role of Dr. William Schmidt, Chief Medical Officer of Ensysce, in the development of PF614-MPAR?

Dr. William Schmidt, Chief Medical Officer of Ensysce, plays a key role in the development and presentation of PF614-MPAR, contributing to its recognition as a potential medical breakthrough and its innovative approach to preventing prescription opioid overdoses.

What is the significance of the Flash Talk designation at the AAPM Meeting?

The Flash Talk designation at the AAPM Meeting is awarded to programs that convey novel information with great potential and are of interest to pain specialists, signifying the significance and potential impact of PF614-MPAR in addressing unmet medical needs.

What is the strategic significance of the End of Phase 2 meeting with the FDA for Ensysce?

The End of Phase 2 meeting with the FDA informs the strategic design of the upcoming Phase 3 studies for PF614-MPAR, contributing to the acceleration of its development as the 'Next Generation' opioid to treat severe pain layered with overdose protective properties.

What is the role of Dr. Lynn Kirkpatrick, PhD, Chief Executive Officer of Ensysce, in the development of PF614-MPAR?

Dr. Lynn Kirkpatrick, PhD, Chief Executive Officer of Ensysce, expresses enthusiasm and confidence in the potential of PF614-MPAR, highlighting its status as a true game-changer and its ability to disrupt the opioid market while mitigating the risk of overdose.

What is the potential impact of PF614-MPAR on the treatment of severe pain?

PF614-MPAR has the potential to herald a new class of treatment for the most severe forms of pain, providing built-in protection against both abuse and overdose, thereby potentially saving lives if approved.

What is the significance of PF614-MPAR being recognized by the AAPM?

The recognition of PF614-MPAR by the AAPM signifies its unique platform and potential for addressing unmet medical needs in the pain field, as well as its innovative approach to preventing prescription opioid overdoses.

What is the role of Dr. William Schmidt, Chief Medical Officer, in the recognition of PF614-MPAR by the AAPM?

Dr. William Schmidt, Chief Medical Officer, plays a key role in the recognition of PF614-MPAR by the AAPM, contributing to its selection as one of the top twelve best topics in the flash talk category and presenting its extremely innovative data to experts and professionals in the pain field.