Ensysce Biosciences, Inc. is providing an update following its recent meeting with the Food and Drug Administration (FDA) regarding its second product, a 'Next Generation' opioid analgesic with overdose protection, PF614-MPAR. The meeting focused on the Company's non-clinical program for the combination product that is designed for the treatment of severe pain. The FDA provided helpful feedback and advice on non-clinical studies that are required for eventual new drug application (NDA) submission and approval.

The guidance will aid in streamlining the development plans for this innovative drug candidate to bring PF614-MPAR to the market as quickly as possible. As recently announced, PF614-MPAR was granted Breakthrough Therapy designation by the FDA which allows more frequent meetings and access to FDA experts. PF614-MPAR is a combination product of PF614, a trypsin-activated abuse protection (TAAP) oxycodone prodrug, and a trypsin inhibitor, nafamostat.

PF614, Ensysce's lead drug candidate and the base for PF614-MPAR, has entered Phase 3 clinical development following its demonstration of efficacy and safety in recent trials and a recent End of Phase 2 meeting with the FDA. The clinical data demonstrated that PF614 delivers oxycodone with the benefit of a longer half-life than products currently on the market, providing what Ensysce believes will be more sustained pain relief with reduced adverse effects that occur following repeat dosing of shorter-acting opioid analgesics. PF614-MPAR takes the product to the next level with overdose protection, by the addition of nafamostat which "switches off" the release of oxycodone when too many doses are ingested simultaneously.

This approach to drug safety is first-in-class and has the potential to beneficially impact many lives.