TRV734 / Trevena - LARVOL DELTA

Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (clinicaltrials.gov) - P2 | N=4 | Completed | Sponsor: National Institute on Drug Abuse (NIDA) | Recruiting ➔ Completed | N=64 ➔ 4 | Trial completion date: Sep 2026 ➔ Feb 2025 | Trial primary completion date: Sep 2026 ➔ Feb 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Substance Abuse

Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: National Institute on Drug Abuse (NIDA) | Trial completion date: Sep 2023 ➔ Sep 2026 | Trial primary completion date: Sep 2023 ➔ Sep 2026

Trial completion date • Trial primary completion date • Substance Abuse

Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: National Institute on Drug Abuse (NIDA) | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Substance Abuse

TRV734 as a Potential Medication for Opioid-Use Disorder: Protocol for a Dose-Finding Pilot and a Proof-Of-Concept Human Laboratory Study (CPDD 2022) - "In humans, intravenous administration of the mu-opioid receptor (MOR) agonist TRV130 decreases moderate-to-severe acute pain and trends towards having fewer side-effects than morphine. We predict that TRV734 will suppress opioid withdrawal symptoms with fewer side-effects than oxycodone. If proven, this will support advancing long-acting formulations of TRV734 for OUD treatment. Even modest increases in the proportion of patients who are unresponsive to buprenorphine or methadone, but who respond to TRV734, would be a significant public health benefit."

Clinical • Addiction (Opioid and Alcohol) • Pain • Substance Abuse

Two-Part Phase 1 Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of TRV734 in Healthy Adults. (PubMed, Clin Pharmacol Drug Dev) - "There was a dose-related decrease in pupil diameter following administration of TRV734 up to TRV734 125 mg every 6 hours. A favorable trend in bowel function index for TRV734 warrants continued study."

Clinical • Journal • P1 data • PK/PD data • Pain

Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (clinicaltrials.gov) - P2; N=53; Recruiting; Sponsor: National Institute on Drug Abuse (NIDA); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Substance Abuse

Trevena initiates clinical development of TRV734, a novel biased ligand for moderate to severe pain (Trevena Press Release) - "Trevena...today announced the initiation of its first Phase 1 trial for TRV734, a novel drug candidate in development as an orally administered treatment for moderate to severe acute and chronic pain....The main objective of this first-in-human trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of TRV734 in healthy subjects."

New P1 trial • Pain

Biased ligands as a path to safer analgesics (oliceridine, TRV734 and TRV250) (CPDD 2018) - No abstract available.

Biosimilar • CNS Disorders • Pain

Trevena pauses enrollment in proof-of-concept clinical trials for TRV250 And TRV734 (Reuters) - “Trevena…announced that enrollment has been paused in proof-of-concept clinical trials for trv250 and trv734….Trevena - withdrawing previous guidance with respect to timing of top line data for TRV250 and TRV734....Announced the U.S. FDA review of the resubmission of NDA for oliceridine is ongoing; Expects the FDA’S PDUFA goal date for completion of the FDA’s review of the NDA for oliceridine to remain August 7, 2020."

Enrollment status • NDA • PDUFA date

Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (clinicaltrials.gov) - P2; N=53; Not yet recruiting; Sponsor: National Institute on Drug Abuse (NIDA)

Clinical • New P2 trial

A First-in-Human Clinical Study With TRV734, an Orally Bioavailable G-Protein-Biased Ligand at the μ-Opioid Receptor. (PubMed, Clin Pharmacol Drug Dev) - "Following administration of TRV734 125 mg under fasted or fed conditions, there was no significant difference in bioavailability when given as a solution or drug in capsule to fasted subjects. When drug in capsule was given to subjects following a high-fat meal, absorption was slowed, resulting in decreased peak concentrations, but area under the plasma concentration-time curve was not affected."

Clinical • Journal • P1 data