Ensysce Biosciences Announces Successful Meeting with FDA for PF614-MPAR, a Next Generation Opioid with Overdose Protection
Ensysce Biosciences, Inc. (NASDAQ:ENSC) receives FDA guidance for its PF614-MPAR program, a 'Next Generation' opioid analgesic with overdose protection. The FDA provided feedback on non-clinical studies required for NDA submission and approval, streamlining development plans. PF614-MPAR, granted Breakthrough Therapy designation, aims to provide sustained pain relief with reduced adverse effects and overdose protection. Ensysce's lead drug candidate, PF614, has entered Phase 3 clinical development, demonstrating efficacy and safety.
The recent FDA guidance for Ensysce Biosciences' PF614-MPAR program is a pivotal development in the pharmaceutical industry, particularly in the context of the opioid crisis. The combination of a trypsin-activated abuse protection (TAAP) oxycodone prodrug, PF614, with a trypsin inhibitor, nafamostat, represents an innovative approach to pain management with inherent overdose protection. This first-in-class drug could significantly alter the landscape of opioid therapeutics by offering a safer alternative for severe pain treatment.
From a medical research perspective, the drug's longer half-life and potential to reduce adverse effects are promising. However, the efficacy of the overdose protection mechanism will be a critical factor in its success. The Breakthrough Therapy designation, which is granted for drugs that demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, underscores the importance of this development. If PF614-MPAR proves to be successful in Phase 3 trials and gains FDA approval, it could set a new standard for opioid medications, emphasizing safety without compromising pain relief.
Ensysce Biosciences' progress with PF614-MPAR has significant financial implications for the company and its investors. The FDA's Breakthrough Therapy designation typically expedites the development and review process, potentially leading to a faster path to market. For Ensysce, a small-cap biotech company, the success of PF614-MPAR could mean a substantial increase in market valuation and investor interest.
The market for pain management drugs, especially those that can mitigate the risk of opioid overdose, is vast. Given the current opioid epidemic, payers and prescribers may prioritize drugs with abuse-deterrent properties, which could translate into a strong market uptake for PF614-MPAR. However, investors should consider the risks inherent in clinical-stage biotech investments, such as potential delays in development, regulatory hurdles and the challenges of commercialization in a competitive market.
The opioid epidemic has been a significant burden on the healthcare system, with substantial costs associated with addiction treatment, overdose management and related healthcare services. Ensysce Biosciences' PF614-MPAR could have a considerable impact on public health and healthcare economics by potentially reducing the incidence of opioid overdoses.
The economic benefits of such an innovation extend beyond direct medical costs. By reducing the number of overdoses, there could be a decrease in emergency room visits, hospitalizations and the need for long-term addiction treatment programs. Moreover, a safer opioid alternative could lead to improved productivity and reduced societal costs by decreasing the prevalence of addiction-related issues. The long-term implications for healthcare policy and reimbursement strategies will be critical to monitor as PF614-MPAR progresses through clinical development and toward commercialization.
02/21/2024 - 08:00 AM
~ PF614-MPAR program receives FDA guidance ~
SAN DIEGO, CA / ACCESSWIRE / February 21, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, is providing an update following its recent meeting with the Food and Drug Administration (FDA) regarding its second product, a ‘Next Generation' opioid analgesic with overdose protection, PF614-MPAR.
The meeting focused on the Company's non-clinical program for the combination product that is designed for the treatment of severe pain. The FDA provided helpful feedback and advice on non-clinical studies that are required for eventual new drug application (NDA) submission and approval. The guidance will aid in streamlining the development plans for this innovative drug candidate to bring PF614-MPAR to the market as quickly as possible.
As recently announced, PF614-MPAR was granted Breakthrough Therapy designation by the FDA which allows more frequent meetings and access to FDA experts. PF614-MPAR is a combination product of PF614, a trypsin-activated abuse protection (TAAP) oxycodone prodrug, and a trypsin inhibitor, nafamostat. PF614, Ensysce's lead drug candidate and the base for PF614-MPAR, has entered Phase 3 clinical development following its demonstration of efficacy and safety in recent trials and a recent End of Phase 2 meeting with the FDA.
The clinical data demonstrated that PF614 delivers oxycodone with the benefit of a longer half-life than products currently on the market, providing what Ensysce believes will be more sustained pain relief with reduced adverse effects that occur following repeat dosing of shorter-acting opioid analgesics. PF614-MPAR takes the product to the next level with overdose protection, by the addition of nafamostat which "switches off" the release of oxycodone when too many doses are ingested simultaneously. This approach to drug safety is first-in-class and has the potential to beneficially impact many lives.
"We are appreciative of guidance provided by the FDA to help us develop PF614-MPAR," commented Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "The fact that we have been granted Breakthrough Therapy status is a sign of the critical nature of this product. As a country, we are still losing two Americans every hour to opioid prescription overdose. My team now has an approach to attack this problem with what we believe will be a game-changing opioid analgesic that has the potential to reduce opioid overdoses while providing better control of severe acute and chronic pain. We also believe that our approach can benefit both new and existing drugs with improved therapeutic outcomes and reduced abuse."
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 .
Definitions
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.
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:
Ensysce Biosciences Investor Relations Contact: ENSC@mzgroup.us
SOURCE: Ensysce Biosciences, Inc.
press release on accesswire.com
What is the name of the company mentioned in the press release regarding the FDA guidance for the PF614-MPAR program?
Ensysce Biosciences, Inc. (NASDAQ:ENSC)
What is the designation granted to PF614-MPAR by the FDA?
Breakthrough Therapy designation
What is the main focus of the PF614-MPAR program discussed in the press release?
Developing a 'Next Generation' opioid analgesic with overdose protection
What is the key benefit of PF614-MPAR according to Ensysce?
Providing sustained pain relief with reduced adverse effects and overdose protection
Who is the Chief Executive Officer of Ensysce?
