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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 has renewed its collaboration with Quotient Sciences to advance the clinical development of its overdose protection platform, PF614-MPAR. This innovative opioid product, designed to prevent overdose by shutting off opioid release when too many pills are ingested, is undergoing a Phase 1b study to evaluate its efficacy and safety across different doses. The study, PF614-MPAR-102, will assess doses of 25 mg, 50 mg, and 100 mg administered twice daily for five days. PF614-MPAR, which has received Breakthrough Therapy designation from the FDA, aims to provide a safer solution for severe pain management and address the ongoing opioid overdose crisis in the U.S.
Ensysce Biosciences reported their first quarter 2024 financial results, highlighting progress in their clinical programs with FDA breakthrough therapy designations for their lead opioid products, PF614 and PF614-MPAR. The company received positive feedback and guidance from the FDA, affirming their path to regulatory approval and commercialization. Ensysce is set to begin Phase 3 clinical trials in the second half of 2024, showcasing their innovative TAAP and MPAR opioids for severe pain relief with reduced abuse potential.
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