Ensysce Biosciences Completes 50% Enrollment for PF614 Clinical Trial
Ensysce Biosciences has enrolled 50% of subjects targeted for interim review in its pivotal Phase 3 clinical trial of PF614, the Company's next-generation opioid candidate engineered to deliver powerful pain relief with built-in abuse protection. Enrollment began in late December 2025 and is progressing rapidly across three U.S. clinical sites: CenExel JBR; CenExel Atlanta; and ERG-HD Research. The study is being led by Dr. Todd Bertoch, Dr. Jessica McCoun, and Dr. D'Aunno, recognized experts in anesthesiology and pain management. The pivotal PF614-301 trial is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of PF614 for the treatment of moderate to severe pain following abdominoplasty. The study is designed to demonstrate PF614's ability to deliver consistent, clinically meaningful post-surgical pain relief using twice-daily dosing. PF614 leverages Ensysce's proprietary chemical activation technology, which is designed to keep the opioid inactive until swallowed, limiting the impact of tampering and dose manipulation while enabling extended-release pain control. This approach is intended to address one of the central challenges in modern pain care: delivering opioid-level efficacy while reducing the risks of abuse and misuse.
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Ensysce Secures Brazilian Patent to Advance Safer Opioid Treatments
- Patent Approval: Ensysce received a Notice of Allowance from the Brazilian Patent Office for its TAAP™ and MPAR® technologies applied to additional opioid families, further strengthening its intellectual property and supporting the global development of safer analgesics.
- Technological Innovation: The application of MPAR® technology in Ensysce's opioids is expected to significantly reduce abuse potential and prevent overdose, enhancing patient safety without compromising pain relief, showcasing the transformative potential of its platforms.
- Market Expansion: This patent not only extends Ensysce's protection in North America and the EU but also strengthens its competitive position in the South American market, aiding the company's global strategy in the analgesic sector.
- Strategic Vision: Ensysce's CEO highlighted that this patent approval complements its recent patent for ADHD and opioid use disorder products, marking a significant step towards developing safer and more effective therapeutic options.
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 trial, marking a significant step towards commercialization and expected to enhance its competitive position in the safe opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection for Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in the field of safe opioid therapeutics.
- Regulatory Milestone: The FDA's endorsement of PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway for commercial-scale production, reducing regulatory risks and enhancing the likelihood of successful approval.
- Capital Financing: Ensysce secured $4 million in convertible preferred stock financing, with the potential for an additional $16 million, significantly enhancing the company's financial flexibility as it advances the PF614 Phase 3 program.
