Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty

Summary

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.

Timeline

Start

2016-05

Primary completion

2016-12

Completion

2017-01

Outcome

Met primary endpoint

paper responder rates of 61.0%, 76.3%, and 70.0% for the 0.1-, 0.35-, and 0.5-mg regimens, respectively, compared with 45.7% for placebo (all P < 0.05) PMID 31162798 ↗

release “Results of APOLLO-2 (abdominoplasty) All three oliceridine dose regimens achieved the primary endpoint” trevena.com ↗

Publications

• Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Morphine	Other / unclassified	1 mg	—
Subject	Oliceridine	Other / unclassified	0.1 mg	Intravenous
Subject	Oliceridine	Other / unclassified	0.35 mg	Intravenous
Subject	Oliceridine	Other / unclassified	0.5 mg	Intravenous

Indications

No indication recorded.