Ensysce Biosciences announces results from oral HAP trial for PF614

Ensysce Biosciences announced results from a key study on the oral human abuse potential of PF614, a potential next generation pain medicine The study met all key endpoints and showed PF614 had significantly lower scores of "Drug Liking" than the oxycodone comparator at both the low and mid doses studied. These results should allow Ensysce to start the next phase of development, by entering into end of phase 2 discussions with the FDA for commencement of phase 3 trials. On the primary endpoint of "Drug Liking at this moment" PF614 produced statistically lower effects than oxycodone at the lowest dose, and statistically significant "Overall Drug Liking" at both the low and mid doses. PF614 also had a significantly longer median time to reach peak levels for "Drug Liking" than oxycodone at all three dose levels, which is important for reducing abuse potential of opioid agents. The secondary endpoint "Take Drug Again" was met at both the low and mid dose of PF614 and was numerically lower than comparator even at the high dose, demonstrating that recreational drug users are less motivated to abuse PF614 compared to immediate-release oxycodone.