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 TAAP 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 TAAPtechnology is poised to capture the opioid market share for PF614 and the other products in its pipeline.
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 TAAP 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 TAAP products in the competitive landscape of abuse-resistant opioid products.