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Ensysce Biosciences, Inc. (NASDAQ:ENSCW) is a clinical-stage company specializing in developing safer prescription drugs utilizing transformative chemistry to enhance drug safety. The company's TAAP(TM) prodrug of oxycodone, PF614, has shown positive results in clinical studies and provides a longer half-life, benefiting severe pain treatment. Ensysce's technology platforms, TAAP(TM) and MPAR(R), aim to provide tamper-proof treatment options to minimize drug abuse and overdose risks, with a focus on reducing medication abuse deaths.
Ensysce Biosciences (NASDAQ:ENSC) announced receiving FDA guidance regarding its lead product, PF614, indicating that pursuing an acute pain indication is advisable. The FDA's non-binding guidance suggests conducting two clinical trials comparing PF614 with a placebo and an immediate-release opioid like oxycodone. This strategy may reduce the development timeline and costs, compared to a chronic pain focus. Ensysce plans to advance PF614 for acute pain while continuing chronic pain development, aiming to complete human abuse potential studies and initiate Phase 3 trials in the upcoming year.
Ensysce Biosciences has announced positive topline results from a human abuse potential (HAP) study of PF614, an innovative oxycodone product designed to deter abuse. The study demonstrated that PF614 resulted in significantly lower peak 'drug liking' compared to traditional oxycodone. This is crucial for its FDA approval process, aligning with the agency's guidance on evaluating abuse potential. The company is committed to advancing this product into Phase 3 studies, addressing a significant need for safer analgesics in chronic pain management.
Ensysce Biosciences (NASDAQ:ENSC) has initiated the PF614-104 study, focusing on the drug's abuse deterrent properties against oxycodone. The trial tests the oral abuse potential of PF614 in non-dependent recreational opioid users, comparing it to oxycodone and placebo. The study's primary outcome is 'Drug Liking,' essential for future commercialization and labeling. Ensysce's TAAP® technology ensures PF614 is inert without trypsin exposure, potentially reducing abuse risks. Preliminary data is expected in early 2023, marking a significant step towards safer opioid alternatives.
Ensysce Biosciences has initiated the PF614-104 trial, a study to evaluate the oral abuse potential of its drug PF614 compared to oxycodone. Conducted by Dr. Brad Vince, this randomized trial aims to demonstrate that PF614 has less drug liking potential, crucial for its abuse deterrent labeling. This follows the company's previous Human Abuse Potential study, reflecting significant progress in PF614's development. With PF614 exhibiting bioequivalence to OxyContin and a longer half-life for sustained pain relief, results are expected in early 2023.
Ensysce Biosciences (NASDAQ:ENSC) announced its participation in the Benzinga All Access investor event on September 23, 2022. Dr. Lynn Kirkpatrick, CEO, will present at 9:20 AM Eastern time, followed by a Q&A session. The event will be available via a live video webcast, with an archived replay on the Benzinga YouTube Channel. Ensysce focuses on developing tamper-proof prescription drugs to enhance drug safety and combat abuse and overdose risks, leveraging its TAAP™ and MPAR™ technologies.
Ensysce Biosciences held a special meeting of stockholders on September 8, 2022, where key resolutions were approved. Stockholders voted in favor of:
- Issuing shares of common stock to certain investors, ensuring compliance with Nasdaq Listing Rule 5635(d).
- Implementing a Reverse Stock Split at a ratio between one-for-five and one-for-twenty.
- Increasing the number of authorized shares of common stock.
The decisions aim to strengthen the company’s capital structure and support ongoing clinical development initiatives.
Ensysce Biosciences has launched a redesigned corporate website highlighting its innovative TAAP and MPAR technology platforms aimed at improving prescription drug safety. The website aims to enhance communication about its unique, tamper-proof pain treatment options and the company's mission to combat drug abuse and overdoses. CEO Dr. Lynn Kirkpatrick emphasized the importance of showcasing their transformative chemistry as they progress towards commercialization. The redesign was executed by London-based Flipside Health, specializing in digital healthcare solutions.
Ensysce Biosciences (NASDAQ:ENSC, OTC:ENSCW), a clinical-stage biotech firm, announced its participation in several upcoming conferences aimed at improving prescription drug safety. Key events include the PAINWeek Conference from September 6-9, 2022, where CEO Dr. Lynn Kirkpatrick will chair a symposium, and the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The meetings will provide opportunities for one-on-one discussions with company executives regarding their transformative technologies for pain management.
Ensysce Biosciences announced the successful completion of the clinical portion of study PF614-103, assessing the nasal abuse potential of its product PF614 compared to oxycodone. This trial is crucial for obtaining Abuse Deterrent labeling from the FDA. Data from the trial is expected in September 2022, and the study aims to demonstrate that PF614 cannot be abused through nasal inhalation. The results will further Ensysce's efforts to market PF614 as a safer pain management option.
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