Trevi Therapeutics Selected to Exhibit Poster at American Society of Nephrology Kidney Week 2014


Title of Abstract: Exploring Clinical and Pharmacological Effects of Nalbuphine HCl Oral Tablets in Hemodialysis Subjects with Pruritus



New Haven, CT, November 11, 2014 - Trevi Therapeutics, Inc. (“Trevi”), a late-stage clinical development company focused on developing Nalbuphine ER for chronic pruritus conditions, was selected to exhibit a poster at the American Society of Nephrology’s Kidney Week 2014, which takes place November 13th-16th at the Pennsylvania Convention Center in Philadelphia, PA.

Poster #TH-PO730, titled “Exploring Clinical and Pharmacological Effects of Nalbuphine HCl Oral Tablets in Hemodialysis Subjects with Pruritus,” reports that Nalbuphine administered as oral nalbuphine HCl ER tablets was safe and well tolerated up to 240 mgs and that there appeared to be a dose-dependent reduction in VAS scores related to itch.

Thomas Sciascia, MD, Trevi’s Chief Medical Officer and the lead author on the paper, will be present at the poster during the Novel Interventions and Screening Approaches to Prevent CKD session, which will take place on Thursday, November 13, from 10:00 AM - 12:00 PM.

Dr. Sciascia said, “We were pleased to learn that Nalbuphine ER appears to be well tolerated in renally impaired patients and that the pharmacokinetics of the drug were not affected by the dialysis process. Also, we believe the proof-of-concept, as measured by the reduction in itch, was compelling and consistent across the patients in the study.  Based on this data, we have initiated a pivotal study in uremic pruritus in 360 patients in the U.S. and Europe, which we expect to report out in mid-2015.”

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. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in mid 2015. 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.

# # #

Media contact: Laura Brophy, (203) 331-7618, mediarelations@trevitherapeutics.com