Ensysce Biosciences, Inc. announced that it has successfully completed Part A of the previously announced clinical study PF614-102, “A Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics (PK) and Safety of Multiple-Ascending Oral Doses (MAD) of PF614 and the Food Effect and Bioavailability/Bioequivalence (BE) of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects,” conducted by Matthew Johnston, MD, PRA Health Sciences, Salt Lake City, Utah. The Part A of the trial evaluated three dose levels of PF614 delivered orally, twice daily for five days to healthy subjects. Additional study participants received OxyContin at three comparable dose levels.

Following completion of each cohort, a positive review from the trial's independent Safety Review Committee allowed the trial to proceed to the next dose level. All three dose levels have now been successfully completed. PF614 is designed as a delayed onset oxycodone prodrug with trypsin-activated abuse protection (TAAP).

TAAP chemical modification inactivates the active ingredient in Ensysce's opioids products including PF614. This provides abuse deterrence, resistance to manipulation and other forms of recreational drug abuse, while providing a high degree of pain relief for those in severe pain. This study builds on the safety and pharmacokinetic results already seen in the prior Phase 1 study and improves the understanding of how PF614 compares to currently available commercial products.