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. A previous Phase 1 trial demonstrated safety and efficacy of our hydromorphone prodrug, PF329, and an IND is open to initiate our PF614 Phase 1 trial in early 2016. The BIO-MD™ technology of PF614 prevents its 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. 


COMMERCIAL OPPORTUNITY

Prescription opioid medications constitute a multi-billion dollar annual market. In 2012, sales of these products were $8.5 billion in the United States and $11.7 billion globally. Annual sales of several extended-release opioid formulations are very robust, including oxycodone ($2.8 billion), oxymorphone ($600 million), morphine ($350 million) and hydromorphone (>$100 million). Effective opioid medications are essential for improving the lives of the 100 million U.S. adults living with chronic pain.

Several abuse-deterrent opioid products are currently marketed or in late-stage clinical development, but they fall short of being resistant to abuse. Current pill/tablet formulations designed to deter abuse are susceptible to simple extraction techniques and fail to prevent abuse when doses are crushed.

Ensysce Biosciences’ proprietary BIO-MD™ platform effectively resists chewing, crushing, injection, and inhalation; fails to release active opioid when subjected to simple extraction; and resists simple kitchen chemistry approaches that can be used to abuse other unprotected and abuse-resistant opioid pill/tablet formulations. Our technology is broadly applicable to all known opioids, as well as other medications that have the potential for abuse. This higher level of abuse-resistance that our drugs demonstrate, coupled with the growing desire that multiple federal agencies including the FDA, have expressed the desire to transition to more abuse-resistant opioid drugs, favorably positions our BIO-MD™ products in the competitive landscape of abuse-resistant opioid products.