FDA Affirms Ensysce's PF614 for Severe Pain Phase 2 Progress

Ensysce Biosciences, a clinical-stage pharmaceutical company, has recently reported the successful conclusion of a significant meeting with the Food and Drug Administration (FDA) concerning its lead analgesic, PF614. The company, which is focused on enhancing prescription drug safety through innovative chemistry, has been granted affirmation on its non-clinical program and has received valuable feedback on the design of its upcoming Phase 3 clinical trials for PF614.

The company has conducted a series of five clinical studies to assess the safety, potential for abuse, and efficacy of PF614 in treating severe pain. The findings have indicated that PF614 is bioequivalent to OxyContin in delivering oxycodone, suggesting it could be a viable alternative for pain management. Notably, PF614 has been identified to possess a longer half-life than OxyContin, which Ensysce believes could enhance its pain-relief capabilities, decrease opioid-related side effects, and facilitate a genuine twice-daily dosing regimen.

In addition to its bioequivalence, PF614 has demonstrated a lower potential for abuse in both nasal and oral studies, with significantly lower scores for "Overall Drug Liking" and the willingness to "Take Drug Again" when compared to the oxycodone comparator. Moreover, a recent study highlighted PF614's significant analgesic effects, confirming earlier pharmacokinetic studies that measured oxycodone levels following oral administration of PF614. These studies have been instrumental in shaping the Phase 3 clinical protocols and have fostered positive discussions with the FDA.

Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed gratitude for the FDA's guidance, which has been instrumental in positioning PF614 for clinical trials and supporting studies designed to minimize regulatory risks. The successful End of Phase 2 meeting is seen as a pivotal step toward regulatory approval, and the insights gained from Phase 2 studies have informed the strategy and design of Phase 3 trials, expected to commence in the latter half of 2024.

Dr. William Schmidt, Ensysce's Chief Medical Officer, highlighted that PF614 is a crucial component of the company's PF614-MPAR combination product, which includes overdose protection and has received the FDA's Breakthrough Therapy Designation. This recognition underscores the innovative approach Ensysce has taken in developing a new class of opioids.

Ensysce Biosciences is leveraging its proprietary technology platforms to develop safer prescription drugs. The company's Trypsin-Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) platforms are aimed at creating tamper-proof pain treatment options that reduce the risk of drug abuse and overdose. Ensysce's products are poised to offer safer alternatives for treating severe pain and preventing medication abuse-related fatalities. The company's platforms are protected by an extensive intellectual property portfolio covering a broad range of prescription drug compositions.

Ensysce Biosciences is committed to advancing the development of PF614, with the goal of providing a safer opioid analgesic option for patients suffering from moderate-to-severe pain. The company's progress and the FDA's guidance underscore the potential of PF614 to transform opioid analgesic care.