Ensysce Biosciences Forms Partnership for PF614 and PF614-MPAR Development and Launch

Ensysce Biosciences, Inc., a clinical-stage pharmaceutical firm focused on developing novel solutions for severe pain relief with a reduced risk of opioid abuse and overdose, announced a significant strategic partnership with a prominent specialty drug manufacturer. This collaboration aims to facilitate the development and commercial rollout of Ensysce's promising drug products, PF614 and PF614-MPAR. The agreement highlights the collective dedication of both entities to secure rapid regulatory approval and streamline the development process of these innovative medications.

As part of this alliance, the specialty drug manufacturer will supply Ensysce with the necessary clinical trial materials, drug products required for regulatory submissions, and the initial commercial batches of PF614 and PF614-MPAR. This comprehensive support will encompass the entire manufacturing process, including packaging, labeling, and distribution of the products, ensuring a smooth progression from regulatory approval to market entry.

Additionally, the drug manufacturer will acquire an equity stake in Ensysce, providing crucial resources for clinical trials and commercialization activities. This partnership also ensures the fulfillment of essential Chemistry Manufacturing and Control (CMC) requirements for the New Drug Application (NDA) submission.

Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, expressed enthusiasm about the partnership, stating, "This collaboration enhances our ability to deliver high-quality drug products for both clinical and commercial use, starting with PF614 and PF614-MPAR. By efficiently managing all aspects of manufacturing, packaging, and distribution, we can concentrate on providing innovative and safer solutions for patients suffering from severe pain."

Ensysce Biosciences is dedicated to creating safer prescription medications through its proprietary technology platforms. The company's Trypsin-Activated Abuse Protection (TAAP TM) and Multi-Pill Abuse Resistance (MPAR®) platforms are designed to develop unique, tamper-resistant treatment options for pain that significantly reduce the risk of drug abuse and overdose. Ensysce's products are expected to offer safer alternatives for treating patients with severe pain and help prevent fatalities caused by medication abuse.

The company's innovative platforms are protected by a comprehensive global intellectual property portfolio, covering a diverse range of prescription drug compositions. Ensysce's efforts align with their mission to address the critical need for safer pain management solutions while mitigating the risks associated with opioid abuse and overdose.

Overall, this strategic partnership represents a substantial milestone for Ensysce Biosciences. It not only bolsters the company's ability to advance its drug products through the development and regulatory approval stages but also supports their ultimate goal of delivering safer, more effective pain relief solutions to patients in need. The collaboration with a leading specialty drug manufacturer underscores the potential of Ensysce's innovative drug products and their commitment to enhancing patient care and safety.