Trevi Therapeutics Initiates Pivotal Study of Nalbuphine ER in Uremic Pruritus

Trevi Therapeutics recently released data from its successfully completed Phase 1 trial in which Nalbuphine ER was well tolerated in hemodialysis patients and established proof-of-concept for Nalbuphine ER in treating uremic pruritus.

Trevi's President and Chief Executive Officer, Jennifer L. Good said, “Approximately 40% of hemodialysis patients have moderate to severe pruritus that significantly impacts their quality of life. There are no approved therapies for this condition. The initiation of this pivotal study of Nalbuphine ER is a significant step forward in the development of a potential therapeutic treatment option for these patients.”

The study, which is a multi-center, randomized, double-blind, placebo-controlled, parallel, three-armed study, will consist of a titration period of two weeks, followed by a six week blinded period on a fixed dose of drug or placebo and a wash-out period. At the end of the wash-out period, patients may be eligible to roll over into a six month open label extension study. The Company expects topline data from this study in the fourth quarter of 2015.

To learn more go to: www.trevitherapeutics.com.