Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based pharmaceutical company Trevena has begun a Phase IIa/b clinical study of TRV130, which the company is developing as a first-line intravenous treatment for patients experiencing moderate to severe acute pain where intravenous administration is preferred.
Subscribe to our email newsletter
TRV130 is a small molecule G protein biased ligand at the mu opioid receptor. Phase IIa/b study is a multicenter, randomized trial designed to assess the effects of TRV130 in patients following bunionectomy surgery.
The double-blind, placebo- and active-controlled, multiple dose study (NCT02100748) study is aimed at evaluating the efficacy and tolerability of TRV130 in the management of postoperative pain using the gold-standard morphine as a benchmark.
The Phase IIa/b clinical study will enroll a total of approximately 400 patients. These patients will undergo first metatarsal bunionectomy and will be then randomized to receive TRV130, morphine or placebo to manage their pain postoperatively.
Pain intensity and pain relief will be measured using validated rating scales at multiple time points up to 48 hours during the study period.
The study will be conducted in 2 parts. In Part 1 (pilot phase, 150 patients), 25 patients per group will be randomized to four doses of TRV130 (1, 2, 3, 4mg every four hours), morphine, or placebo.
In Part 2, approximately 10 cohorts each of 25 patients will be randomized successively to two adaptive doses of TRV130, morphine and placebo, allowing the trial to focus on-going recruitment on the optimal doses of TRV130 versus morphine.
Trevena expects top line data from the Phase 2a/b clinical study in the first quarter of 2015. This study is designed to facilitate the ensuing Phase III development by providing information on dose- and interval-ranging and furthering the differentiation of TRV130 versus morphine.
Trevena CEO Dr Maxine Gowen noted that this study has been designed to explore dose-regimens of TRV130 in a robust postoperative pain setting in order to support subsequent Phase 3 development.
"This trial reflects our confidence in the profile of TRV130 by directly comparing its therapeutic window to that of morphine," Dr Gowen added.
According to Trevena, the bunionectomy trial’s results will build upon data from the Phase I clinical studies of TRV130.
Recently, Trevena has completed a Phase Ib pharmacokinetic/pharmacodynamic trial comparing TRV130 with morphine in healthy subjects, using an evoked pain model. The company will present full results of the Phase Ib trial at the American Pain Society meeting in May 2014.