Jul. 2 at 1:55 PM
$ENSC PF614-MPAR received FDA Breakthrough Therapy designation. The only opioid formulation in the field to do so for oral overdose protection.
The designation reflects something specific: the FDA reviewed Ensysce's mechanism and concluded it offered substantial improvement over existing therapies on a clinically significant endpoint. It is the agency's own read after evaluating the clinical evidence.
Most abuse-deterrent formulations address misuse from the outside. Ensysce engineered PF614-MPAR to address what happens when the drug is taken orally and in excess. That is a different problem, and until now, an unsolved one. The FDA recognized the difference.
Today, that recognition is advancing into its next chapter. Ensysce has enrolled the first patient in Part 3 of the PF614-MPAR-102 study, the final stage of a program built to deliver the data that will define this approach.
