Proof-of-concept study with pharmacokinetics demonstrates anti-pruritic activity of oral nalbuphine ER in hemodialysis patients with uremic pruritus
New Haven, CT, May 9, 2014 - Trevi Therapeutics, Inc. (“Trevi”), a clinical stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, will exhibit a poster with the results of a recently completed Phase 1 proof-of-concept study at the 2014 Annual Meeting of the Society for Investigative Dermatology in Albuquerque, NM being held May 7-10.
Poster #567, titled “A proof-of-concept study with pharmacokinetics demonstrating anti-pruritic activity of oral nalbuphine in hemodialysis patients with uremic pruritus,” will be displayed at the Society for Investigative Dermatology meeting being held in Albuquerque, New Mexico. The poster reports results from Trevi’s recently completed Phase 1 study which studied the impact on uremic pruritus following oral administration of Nalbuphine ER in fourteen hemodialysis subjects with pruritus. Nalbuphine ER was dose escalated every three days from 30 mg to 240 mg BID over 17 days. A dose-dependent decrease in itch was noted in 13 out of 14 patients. The study appears to establish a relationship between AUC, Cmax, and Cmin and change in VAS score.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said “Nalbuphine ER was shown to be well tolerated in patients on hemodialysis with itch and established proof-of-efficacy in uremic pruritus. We also established safety across a broad dose range. We are advancing Nalbuphine ER in development, and will initiate two efficacy trials in mid-2014 to determine its effectiveness in treating two debilitating medical conditions: uremic pruritus and prurigo nodularis.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical stage biotechnology 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 dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.
Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, 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.
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