Ensysce Biosciences Announces Positive End of Phase 2 Meeting with FDA for PF614 to Treat Severe Pain
Ensysce Biosciences, Inc. announces successful completion of End of Phase 2 meeting with FDA regarding its lead analgesic, PF614. The meeting facilitated affirmation of non-clinical program and constructive ideas exchange for Phase 3 trial designs. Clinical data shows PF614 is bioequivalent to OxyContin with a longer half-life, lower abuse potential, and significant analgesic activity. Phase 3 trials expected to begin in mid-2024.
The announcement of Ensysce Biosciences completing their End of Phase 2 meeting with the FDA is a critical juncture in the drug development lifecycle. The Phase 3 clinical trial is the final stage before a new drug application (NDA) and is pivotal in determining the safety and efficacy of PF614 on a larger population. Given the opioid crisis, the development of a 'Next Generation' analgesic with a potentially safer profile could have significant market implications.
PF614's bioequivalence to OxyContin, coupled with a longer half-life, suggests a competitive advantage in the pain management market. The drug's ability to offer twice daily dosing may improve patient compliance and outcomes. Furthermore, the lower scores for 'Overall Drug Liking' and willingness to 'Take Drug Again' indicate a reduced abuse potential, addressing a critical public health concern. These factors could lead to a favorable market reception, potentially capturing market share from existing opioid treatments.
However, the success of the Phase 3 trials and subsequent commercialization will depend on the ongoing demonstration of PF614's safety and effectiveness. Investors should monitor the progress of the trials and any emerging data on efficacy and side effects. The Breakthrough Therapy Designation for the PF614-MPAR combination product underscores the innovative potential of Ensysce's pipeline and could expedite the regulatory process.
Ensysce Biosciences' progress with PF614 is noteworthy within the context of the opioid market, which is under intense scrutiny due to the high rates of addiction and abuse. A new analgesic with a longer half-life and lower abuse potential could be well-received by both the medical community and patients, potentially leading to a shift in prescribing practices.
From a market perspective, the introduction of PF614 could disrupt the current opioid market dynamics. If the Phase 3 trials confirm the drug's benefits, Ensysce could secure a significant portion of the pain management market. The company's stock could see increased investor interest as the market anticipates potential FDA approval and market entry.
It is important to consider the competitive landscape, including how existing and other pipeline drugs may respond to PF614's market entry. The opioid market is crowded and differentiation is key. Ensysce's strategy to emphasize safety and reduced abuse potential could position PF614 favorably in the eyes of regulators, healthcare providers and patients.
The opioid epidemic has been a driving force for policy changes in pain management and drug approval standards. Ensysce's PF614 appears to align with the FDA's and public health organizations' goals of reducing opioid misuse. The drug's longer half-life and reduced abuse potential may lead to changes in prescribing guidelines and insurance coverage, favoring safer opioid alternatives.
Policy implications of a successful PF614 could extend to increased funding for opioid addiction prevention and treatment programs, as well as support for research into alternative pain management therapies. The regulatory path for PF614, particularly with its Breakthrough Therapy Designation, may also influence future FDA guidance on opioid approvals.
Stakeholders, including policymakers and healthcare providers, will likely monitor PF614's development closely. Its success could catalyze further policy initiatives aimed at curbing opioid abuse while ensuring access to effective pain management solutions.
01/31/2024 - 08:00 AM
~ PF614 Phase 3 Program Expected to Begin Enrollment in Mid-2024 ~
SAN DIEGO, CA / ACCESSWIRE / January 31, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced the completion of a constructive End of Phase 2 meeting with the Food and Drug Administration (FDA) regarding its lead ‘Next Generation' analgesic, PF614. The meeting facilitated an affirmation of the Company's non-clinical program and enabled an exchange of constructive ideas regarding Ensysce's Phase 3 clinical trial designs for PF614.
As previously announced, the Company has performed five clinical studies to evaluate the safety, abuse potential and efficacy of PF614 for the treatment of severe pain. The clinical data has demonstrated that PF614 was bioequivalent to OxyContin for delivering oxycodone, meaning one could easily substitute PF614 for OxyContin in patients with pain. However, PF614 was found to have a longer half-life than OxyContin. Ensysce believes that the longer twelve-hour half-life could improve the pain-relieving qualities of PF614, reduce opioid-related adverse events, and provide true twice daily dosing. Evaluation of both nasal (insufflation) and oral abuse‑potential studies met key endpoints that showed PF614 had significantly lower scores for "Overall Drug Liking" and willingness to "Take Drug Again" than the oxycodone comparator.
Additionally, PF614 showed significant analgesic activity in a recent study that measured the time-of-onset of pain-relief in healthy volunteers. The study confirmed the prior clinical pharmacokinetic studies that measured oxycodone blood levels following oral administration of PF614 and showed that Ensysce's TAAP chemical approach delivers strong analgesia. This study was key to the design of the Company's Phase 3 clinical protocols and positive discussions with the FDA.
"We are appreciative of the guidance provided by the FDA to help us properly position PF614 as we progress through clinical trials and supporting studies in order to mitigate the risk of regulatory hurdles in our go-to market plan," commented Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "The successful outcome of the End of Phase 2 meeting with the FDA signifies a major step in the regulatory approval process of PF614. In addition, the results and analysis from our Phase 2 study have informed our strategy and design of Phase 3 studies expected to begin in the second half of 2024. In summary, as we advance to Phase 3 trials of PF614, we have gained further conviction that we are creating the "Next Generation" of opioid analgesic care with a safer option for patients in moderate-to-severe pain."
Dr. William Schmidt, Chief Medical Officer of Ensysce added, "PF614 is the key opioid component of the Company's PF614-MPAR ‘next-generation' combination product with overdose protection that received the FDA's Breakthrough Therapy Designation, as announced on January 23, 2024. This designation illustrates the innovative approach Ensysce has adopted in the development of this family of novel opioids."
About Ensysce Biosciences 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 .
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.
Ensysce Biosciences Company Contact:
Ensysce Biosciences Investor Relations Contact: ENSC@mzgroup.us
SOURCE: Ensysce Biosciences, Inc.
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What is the status of Ensysce Biosciences, Inc.'s PF614 Phase 3 Program?
The Phase 3 program is expected to begin enrollment in mid-2024.
What is the FDA's response to Ensysce Biosciences, Inc.'s PF614 Phase 3 Program?
The FDA facilitated an affirmation of the Company's non-clinical program and enabled an exchange of constructive ideas regarding Ensysce's Phase 3 clinical trial designs for PF614.
What are the key findings from Ensysce Biosciences, Inc.'s clinical studies on PF614?
The clinical data shows that PF614 is bioequivalent to OxyContin with a longer half-life, lower abuse potential, and significant analgesic activity.
What is the significance of PF614's longer half-life compared to OxyContin?
The longer twelve-hour half-life of PF614 could improve the pain-relieving qualities, reduce opioid-related adverse events, and provide true twice daily dosing.
What is the FDA's Breakthrough Therapy Designation for Ensysce Biosciences, Inc.'s PF614-MPAR combination product?
The FDA's Breakthrough Therapy Designation illustrates the innovative approach Ensysce has adopted in the development of this family of novel opioids.
