Oxytrex (oxycodone & naltrexone) / Cassava - LARVOL DELTA

Evaluation of Oral PF614 Relative to OxyContin (PF614-102) (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Ensysce Biosciences | Phase classification: P1b ➔ P1

Phase classification

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=111 | Completed | Sponsor: Ensysce Biosciences | Active, not recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Apr 2023

Trial completion • Trial completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=111 | Active, not recruiting | Sponsor: Ensysce Biosciences | Recruiting ➔ Active, not recruiting | N=64 ➔ 111 | Trial completion date: Feb 2023 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Ensysce Biosciences | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Nov 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date

Evaluation of Oral PF614 Relative to OxyContin (clinicaltrials.gov) - P1b | N=84 | Completed | Sponsor: Ensysce Biosciences | Recruiting ➔ Completed

Trial completion

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Ensysce Biosciences | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2022 ➔ Nov 2022 | Trial primary completion date: Apr 2022 ➔ Nov 2022

Enrollment open • Trial completion date • Trial primary completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1; N=64; Not yet recruiting; Sponsor: Ensysce Biosciences

Clinical • New P1 trial

A Phase 1b, Randomized, 2-Part Evaluation of Oral PF614 Relative to OxyContin (clinicaltrials.gov) - P1b; N=84; Recruiting; Sponsor: Ensysce Biosciences

Clinical • New P1 trial

SAD: Study of PF614 Compared to OxyContin® in Healthy Volunteers (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Ensysce Biosciences; Completed ➔ Recruiting; N=48 ➔ 64; Trial primary completion date: Apr 2017 ➔ Jan 2018

Enrollment change • Enrollment open • Trial primary completion date • Biosimilar

Emerging therapies for patients with symptoms of opioid-induced bowel dysfunction. (PubMed) - "Thus, a complex assessment and management that addresses underlying causes and patomechanisms of OIBD is recommended. Newer strategies comprise methylnaltrexone or OXN administration in the management of OIBD, and OXN may be also considered as a preventive measure of OIBD development in patients who require opioid administration."

Review • Biosimilar • Oncology • Pain