Four clinical studies planned to start in
second half of 2019
PF614: PRODRUG OF OXYCODONE
PF614 is our lead abuse-resistant opioid drug program. We have made it our priority program due to the crisis of oxycodone abuse and the urgent need for a more abuse-resistant form of this important pain therapy.
A Phase 1 clinical trial was completed in 2017 which evaluated the safety and pharmacokinetic release of oxycodone from PF614, comparing it to Oxycontin. Healthy subjects were randomized to receive an oral solution of PF614 (n=6 per cohort; 15 to 200 mg) or Oxycontin tablets (n=2 per cohort; 10 to 80 mg).
The pharmacokinetic data for PF614 demonstrated an extended release profile for oxycodone and a 12 hr half-life that will provide a true twice-a-day dosing regimen.
Safety data showed that PF614 is well tolerated with no unexpected safety concerns at all of the doses evaluated.
In January 2018, FDA granted Fast Track designation for development of PF614. Multi-Ascending Dose and Human Abuse Liability studies are planned to begin 2019.
Full details at ClinicalTrials.gov, ID # NCT02454712.
PF329: ER HYDROMORPHONE PRODRUG
Early-stage clinical trials were conducted with PF329, an extended-release prodrug of hydromorphone.
In two phase 1 studies, PF329 has demonstrated excellent safety, dose proportionality, and a clinically beneficial extended release profile.
A Fast Fed study showed little effect on activation of PF329 or its pharmacokinetic profile.
We have achieved human proof of concept for PF329.
Fisher et al, First-in-man evaluation of PF329, an abuse-resistant prodrug of hydromorphone.
Journal of Pain 2012;13(4): S76