Trevena begins Phase IIb trial of TRV130 to treat acute postoperative pain

TRV130 is being developed as a first-line intravenous treatment for patients experiencing moderate-to-severe acute pain.

The multicenter, randomized, double-blind, placebo- and active-controlled clinical trial is designed to evaluate the efficacy and tolerability of TRV130 in the management of postoperative pain following abdominoplasty surgery, a representative soft tissue surgery.

Trevena chief executive officer Maxine Gowen said: "This study complements our highly successful Phase II study of TRV130 following bunionectomy surgery by evaluating TRV130 following a soft tissue surgery.

"We believe that the use of patient-controlled analgesia will provide another important measure of TRV130’s therapeutic profile as compared to morphine by allowing patients to optimize dosing of both drugs."

The trial will include morphine as a benchmark and use a flexible dose, patient-controlled analgesia (PCA) administration regimen intended to optimize treatment and reflect the as-needed dosing most commonly used with post-operative opioid analgesics.

During the trial, around 200 patients will be assigned randomly to a post-operative regimen of TRV130, placebo, or morphine, in a 2:1:2 ratio respectively, for 24 hours after surgery, beginning when post-operative pain becomes moderate or severe in intensity.

According to the company, treatment in the trial will start with a double-blind loading dose of TRV130, morphine or placebo, after which each patient can self-administer lower doses as needed for pain relief.