oxycodone ER (PF614) / Ensysce Biosciences - LARVOL DELTA

Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Ensysce Biosciences | N=30 ➔ 54 | Trial completion date: Dec 2026 ➔ Apr 2027 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date

Formulation development and a Phase 1 clinical study of PF614-MPAR, an oxycodone prodrug with oral opioid overdose protection. (PubMed, J Opioid Manag) - "PF614-MPAR may be the first opioid with both abuse resistance and oral overdose protection."

Journal • P1 data • Addiction (Opioid and Alcohol) • CNS Disorders

Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Ensysce Biosciences | N=50 ➔ 30 | Trial completion date: Mar 2026 ➔ Dec 2026 | Trial primary completion date: Jan 2026 ➔ Jul 2026

Enrollment change • Trial completion date • Trial primary completion date

PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301) (clinicaltrials.gov) - P3 | N=320 | Recruiting | Sponsor: Ensysce Biosciences | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2026 ➔ Nov 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Enrollment open • Trial completion date • Trial primary completion date • Aesthetic Medicine • Pain

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Ensysce Biosciences | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Ensysce Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Ensysce Biosciences | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: Jun 2026 ➔ Sep 2025

Trial completion date • Trial primary completion date

CPT: Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201) (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Ensysce Biosciences

New P2 trial • Pain

PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301) (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Ensysce Biosciences

New P3 trial • Aesthetic Medicine • Pain

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

Phase classification

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Ensysce Biosciences

New P1 trial

Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers. (PubMed, Clin Transl Sci) - "Additionally, PF614 provided similar oxycodone exposures following both fasted and fed states. This study confirms findings from our single-ascending dose study, showing that PF614 100 mg releases oxycodone with a PK profile comparable to 40 mg OxyContin under both fasted and fed conditions and with a similar safety profile under naltrexone-blocked conditions."

Journal

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

PF614-MPAR: A Novel Trypsin Activated Abuse Protected (TAAP) Extended-Release Oxycodone Prodrug with Overdose Protection (PAINWeek 2023) - "Cohorts of 12 to 15 naltrexone-blocked healthy subjects received PF614 25 mg alone or 1, 2, 3, 5 or 8 dose units of PF614-MPAR all at once in six treatment periods; pharmacokinetic samples were taken over a 72 hr period after dosing followed by a 5-day washout between each treatment... PF614-MPAR represents the first opioid product that can deliver oxycodone in an extended-release profile that may protect against all four forms of abuse including snorting, chewing, injecting and oral overdose."

Addiction (Opioid and Alcohol) • CNS Disorders

Intranasal and Oral Human Abuse Potential (HAP) Studies with PF614: A Novel Trypsin Activated Abuse Protected (TAAP) Extended-Release Oxycodone Prodrug (PAINWeek 2023) - "Purpose/Objectives: In previous clinical studies, a 100 mg dose of TAAP oxycodone, PF614, was shown to be bioequivalent to OxyContin 40 mg but with a slow onset of action and a nearly 3x longer half-life than OxyContin (12 hr versus 4.4 hr, respectively). Both intranasal and oral PF614 showed significantly less abuse potential than IR oxycodone. Intravenous (IV) abuse deterrent studies have not been required by the FDA since IV administered PF614 will never be exposed to trypsin and hence will pass out of the body in an inactive form. Previous studies (Kirkpatrick et al., 2017) show that the abuse-resistance of PF614 is unaffected by simple physical manipulations (e.g., extraction and/or chewing of the dose form) and cannot be manipulated using culinary enzymes, common solvents, or household chemicals at either room temperature or elevated temperatures to release active oxycodone without destroying 90% or more of the parent molecule."

CNS Disorders

PDM-06 - Severe Pain, Next Generation Solutions – PF614/ PF614-MPAR (PAINWeek 2023) - "Understand the links between pain, mental illnesses, and other critical factors. Learn about 2 new approaches coming soon, including a potentially non-abusable opioid and a product which protects against overdose."

Addiction (Opioid and Alcohol) • CNS Disorders • Pain

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

Intranasal Human Abuse Potential of PF614: A Novel 'Next Generation' Trypsin Activated Abuse Protected (TAAP) Opioid (CPDD 2023) - "In previous studies, a 100 mg dose of TAAP oxycodone, PF614, was shown to be bioequivalent to OxyContin 40 mg, but with a significantly longer (12 hr versus 4.4 hr respectively) half-life. Intranasal PF614 showed significantly less abuse potential than IR oxycodone. PF614 could represent a new class of ‘Next Generation of Opioids’ that require trypsin activation and cannot be manipulated to release an immediate-onset drug load. Financial Support Supported by: Ensysce Biosciences Inc."

Late-breaking abstract

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Ensysce Biosciences | Active, not recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol)

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

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Ensysce Biosciences | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2023 ➔ Jan 2023

Enrollment closed • Trial completion date • Addiction (Opioid and Alcohol)

A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Ensysce Biosciences | Active, not recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol)

"$ENSC $ENSCW Ensysce Biosciences Announces FDA Guidance on the Clinical Development Pathway for PF614 https://t.co/W614kFC5bm" (,@stock_titan)

Clinical

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Ensysce Biosciences

New P1 trial • Addiction (Opioid and Alcohol)

A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Ensysce Biosciences

New P1 trial • Addiction (Opioid and Alcohol)