Ensysce Biosciences Announces FDA Breakthrough Therapy Designation Granted for PF614-MPAR
Ensysce Biosciences, Inc. receives Breakthrough Therapy Designation (BTD) from the FDA for PF614-MPAR, a next-generation opioid with oral overdose protection. BTD is granted to drugs intended to treat serious conditions with potential for substantial improvement over available therapies. PF614-MPAR aims to provide pain relief while limiting accidental or intentional overdose, addressing the crisis of prescription overdose deaths in the US. The designation facilitates expedited development and review processes, highlighting the advancement made by Ensysce in treating severe pain.
The FDA's Breakthrough Therapy Designation (BTD) for Ensysce Biosciences' PF614-MPAR is a significant milestone for the company and the pharmaceutical industry at large. The BTD expedites the development and review process for drugs that show potential in treating serious conditions with substantial improvements over existing therapies. This designation can be a major catalyst for a company's stock performance, as it often leads to increased investor confidence and can significantly shorten the time to market for the drug in question.
From a pharmaceutical development perspective, PF614-MPAR's unique mechanism that aims to prevent oral overdose is a notable innovation in the opioid space, which has been plagued by high rates of abuse and overdose. The ability to 'shut down' opioid release at excessive doses could position PF614-MPAR as a safer alternative to current opioids, potentially leading to widespread adoption if clinical efficacy and safety are proven in subsequent trials.
For stakeholders, the short-term benefits include potential stock price appreciation due to positive market sentiment following the BTD. In the long-term, the successful development and commercialization of PF614-MPAR could lead to significant revenue streams for Ensysce Biosciences, especially considering the current demand for safer pain management options.
The opioid crisis has been a public health emergency for years, with overdose deaths reaching alarming rates. Ensysce Biosciences' approach with PF614-MPAR could represent a paradigm shift in pain management by addressing two critical issues: efficacy in pain relief and reducing the risk of overdose. The clinical evidence leading to the BTD suggests that PF614-MPAR may have a favorable risk-benefit profile, which is crucial for drugs in this category.
Investors and stakeholders should note that while BTD is a positive indicator of a drug's potential, it does not guarantee eventual FDA approval. The drug still needs to go through rigorous Phase 2 and Phase 3 clinical trials to demonstrate safety and efficacy in a larger population. However, BTD does provide the company with benefits such as more frequent meetings with the FDA and eligibility for rolling review, which could streamline the development process.
It's important to monitor the progress of the ongoing clinical trials for PF614-MPAR to assess the likelihood of successful FDA approval and commercial launch. The implications for the opioid market could be substantial, as there is a strong demand for safer alternatives to traditional opioids.
The market potential for a safer opioid alternative like PF614-MPAR is considerable, given the ongoing opioid epidemic in the United States. The BTD from the FDA signals that PF614-MPAR could fill a significant unmet need in the market for pain medications with reduced risk of abuse and overdose. This could disrupt the current opioid market, leading to shifts in prescribing practices and potentially capturing a significant market share.
An analysis of the competitive landscape is essential to understand how PF614-MPAR might fit into the broader market. If approved, Ensysce Biosciences would need to navigate market access challenges, including payer reimbursement, provider adoption and patient awareness. The company's strategy for commercialization will be critical to the success of PF614-MPAR.
Investors should consider the broader implications of a successful BTD, including the potential for strategic partnerships or acquisition interest from larger pharmaceutical companies looking to enhance their pain management portfolios. Such developments could further influence Ensysce Biosciences' stock performance and market valuation.
01/23/2024 - 08:00 AM
~ FDA acknowledges significant potential impact of MPAR's oral overdose protection ~
SAN DIEGO, CA / ACCESSWIRE / January 23, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced receipt of notice from the U.S Food and Drug Administration (FDA) that it has granted Breakthrough Therapy Designation (BTD) for PF614-MPAR. A next generation opioid, PF614-MPAR represents a major scientific innovation, as it is what we believe to be the first product with oral overdose protection in any drug class.
BTD is a rarely used designation, having been granted to fewer than 300 drugs. It is designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
Prescription overdose deaths in the US remain at a crisis point and the latest figures from the Centers for Disease Control indicate almost two overdose deaths per hour. Safer opioids to treat severe pain while providing protection against abuse and oral overdose are vital to reverse this tragic trend and Ensysce is forging the way with two new opioids in clinical development.
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.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, commented, "We are highly encouraged with the receipt of Breakthrough Therapy Designation by the FDA based on the data we generated in our Phase 1 study, PF614-MPAR-101, that demonstrated our approach can provide protection from taking too many opioids orally. This is unique for the opioids class. We previously received Fast-Track Status for PF614, and this recognition of BTD for PF614-MPAR highlights the advancement we have made with our approach to treating severe pain. BTD facilitates our ability to expedite our programs through the approval processes in an efficient manner, with rolling review of both programs. We believe our goal of bringing the ‘next generation' of analgesics for severe pain to those in need is becoming a reality."
The primary intent of BTD is to develop evidence needed to support approval as efficiently as possible. The designation provides all the features of Fast Track designation including accelerated approval and priority review along with intensive guidance involving senior managers on an efficient drug development program.
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 (TAAPTM ) 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.
Ensysce Biosciences Investor Relations Contact:
Shannon DevineENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
press release on accesswire.com
What is the significance of the Breakthrough Therapy Designation (BTD) granted to PF614-MPAR by the FDA?
BTD is granted to drugs intended to treat serious conditions with potential for substantial improvement over available therapies. It facilitates expedited development and review processes, providing accelerated approval and priority review along with intensive guidance involving senior managers on an efficient drug development program.
What is the purpose of PF614-MPAR, the next-generation opioid with oral overdose protection?
PF614-MPAR aims to provide optimal pain relief at prescribed doses while limiting accidental or intentional overdose by 'shutting down' opioid release if too much active drug is consumed. Each capsule contains built-in protection against both abuse and overdose which plague traditional opioids.
What is the primary intent of Breakthrough Therapy Designation (BTD) by the FDA?
The primary intent of BTD is to develop evidence needed to support approval as efficiently as possible. The designation provides all the features of Fast Track designation, including accelerated approval and priority review along with intensive guidance involving senior managers on an efficient drug development program.
Who is the Chief Executive Officer of Ensysce Biosciences?
Dr. Lynn Kirkpatrick is the Chief Executive Officer of Ensysce Biosciences.
