PF-614 is under clinical development by Ensysce Biosciences and currently in Phase I for Pain. According to GlobalData, Phase I drugs for Pain have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how PF-614’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

PF-614 overview

PF-614 (oxycodone prodrug ER) is under development for the treatment of pain and substance (drug) abuse. The drug candidate is an extended-release formulation administered orally. It is an abuse-resistant opioid prodrug based on Bio-MD technology. PF-614 acts by targeting mu opioid receptor (MOR or OP3 receptor). It is developed based on Trypsin-Activated Abuse Protection (TAAP) technology. It is administered through intranasal route for the treatment of  substance (drug) abuse.

Ensysce Biosciences overview

Ensysce Biosciences is a biotechnology company. It offers proprietary abuse-resistant opioid prodrug technology. The company’s pipeline products include oxycodone, hydromorphone, ADHD, PF614, and PF329. Ensysce Biosciences PF614 is a lead abuse-resistant opioid drug is a proprietary prodrug of oxycodone and PF329, an extended-release prodrug of hydromorphone. Ensysce Biosciences offers abuse resistant technology, TAAP technology, pain medications, MPAR technology, single walled carbon nanotubes technology, drug delivery, and research direction solutions. It provides its products and services to healthcare, medical and pharmaceutical sectors. Ensysce Biosciences is headquartered in San Diego, California, the US.

For a complete picture of PF-614’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.