Presentation Abstract: Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCI ER Tablets in Hemodialysis Patients with Uremic Pruritus
New Haven, CT, October 29, 2015 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, will make an oral abstract presentation on their recent Phase 2/3 clinical trial of Nalbuphine HCI ER tablets at the American Society of Nephrology's Kidney Week 2015, in San Diego, CA on November 7 at 12:00 pm PT in Hall D.
The presentation is based on Trevi’s late-breaking clinical trial, submitted as Abstract 6166: “Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCI ER Tablets in Hemodialysis Patients with Uremic Pruritus,” and will be presented during the meeting’s High-Impact Clinical Trials session by Dr. Vandana Mathur, a nephrologist and key opinion leader in uremic pruritus.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said, “Uremic pruritus is a debilitating chronic condition which significantly affects quality of life. Despite the fact that 60% of dialysis patients suffer from pruritus, there are currently no approved treatments in the US or Europe. We were very pleased with the statistically significant results of Nalbuphine ER in this trial, and look forward to furthering the development of our drug in this condition.”
In other activity at Kidney Week 2015, Trevi will also exhibit Poster #TH-PO576 “A Multicenter, Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for the Treatment of Uremic Pruritus: Baseline Population Characteristics.” The authors from the poster will be available on November 5, 2015 from 10:00 am PT to 12:00 pm PT to answer any questions.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic pruritic dermatologic condition characterized by the presence of nodules on the skin. There are no approved therapies in the U.S. or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch. Because of Nalbuphine ER’s unique dual mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials, the Company believes it can have broad utility in treating chronic pruritus.
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.