Presentation Abstract: Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritus
New Haven, CT, March 1, 2016 – Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company developing Nalbuphine ER for chronic pruritus conditions, will make an oral abstract presentation on the Company’s recent Phase 2/3 clinical trial of Nalbuphine HCI ER tablets at the 74th American Academy of Dermatology Annual Meeting in Washington, DC on Saturday, March 5, at 10:30 am, Eastern.
The presentation is based on Trevi’s recently completed uremic pruritus trial, submitted as Abstract 3723: “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.” The data will be presented during the meeting’s Late-breaking Research Forums – Clinical Trials session by Dr. Jayant Kumar, a nephrologist and investigator in the trial.
Jayant Kumar, MD, the lead enrolling investigator in this trial, said, “Uremic pruritus is a debilitating chronic condition which significantly affects the quality of life of dialysis patients. Despite the fact that 60% of these patients suffer from pruritus, there are currently no approved treatments in the U.S. or Europe. We had strong patient interest in this trial, and look forward to further development work on this condition.”
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.
Katie McManus
(203) 903-9627
k.mcmanus@trevitherapeutics.com
Trevi Therapeutics
195 Church Street, 14th Floor
New Haven, CT 06510
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