29 January 2018 - Ensysce Biosciences is pleased to announce that the FDA has granted Fast Track designation for the development of PF614 for management of moderate to severe chronic pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

PF614 is an extended-release oxycodone prodrug designed with a two-step enzyme activation process that provides abuse deterrent properties and limiting its use to oral administration. A recently completed Phase 1 trial “A Phase 1, Single-Center, Dose-Escalation Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of PF614 in Healthy Subjects Compared to OxyContin” demonstrated the safety and the extended release characteristics of this prodrug approach to opioid delivery.

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