PF614: Prodrug of Oxycodone
PF614, our lead abuse-resistant opioid drug is a proprietary prodrug of oxycodone. Extended-release oxycodone had $2.8 billion in sales in 2012, and is subject to tampering and abuse that is associated with a significant number of deaths. The BIO-MD™ technology of PF614 prevents all non-oral use and provides an analgesic profile that is similar to oxycodone. Its tamper resistant composition makes it a leader in this field where others have relied just on the formulation approach to overcome abuse. Ensysce’s BIO-MD™ technology is poised to capture the opioid market share for PF614 and the other products in its pipeline. In January 2018, the FDA granted Fast Track designation for development of PF614.
A Phase 1 clinical trial was initiated in November 2016 to evaluate the safety and pharmacokinetic release of oxycodone from PF614, comparing it to Oxycontin. Healthy subject, randomized to receive an oral solution of PF614 (n=6 per cohort) or Oxycontin (n=2 per cohort) enrolling up to 6 cohorts.
The pharmacokinetic data to date demonstrates an extended release profile for oxycodone that suggests a twice-a-day dosing regimen.
Safety data to date shows that PF614 is well tolerated with no unexpected safety concerns at the doses evaluated.
Full details at ClinicalTrials.gov, ID # NCT02454712.
Multi-Ascending Dose and Human Abuse Liability studies are planned for 2018.