Trevi Therapeutics starts pivotal study of Nalbuphine ER in hemodialysis patients

The study is designed to assess the safety and anti-pruritic efficacy of Nalbuphine ER tablets in about 360 hemodialysis patients to be enrolled in the US and Europe.

Recently, the company had released data from its completed Phase I trial in which Nalbuphine ER was seen to be well tolerated in hemodialysis patients and established proof-of-concept for Nalbuphine ER in treating uremic pruritus.

Trevi president and chief executive officer Jennifer Good said about 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," Good said.

The trial’s primary endpoint will measure the change from worst itch at baseline in patients with moderate to severe uremic pruritus, treated with two doses of Nalbuphine ER.

Secondary endpoints in the trial include patient perception of the burden of itch, quality of life effects of pruritus, and impact on sleep, anxiety and depression.

The company intends to report topline data from the trial in the fourth quarter of 2015.

Image: Topline results from Trevi’s trial of Nalbuphine ER will be reported in the fourth quarter of 2015. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net