Title of Abstract: Pharmacokinetics of Nalbuphine Hydrochloride Extended Release Tablets in Hemodialysis and Healthy Subjects following Multiple Escalating Oral Doses
New Haven, CT, September 9, 2014 - Trevi Therapeutics, Inc. (“Trevi”), a late-stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, was selected to exhibit a poster at the 2014 Annual Meeting of the American College of Clinical Pharmacology, which takes place September 14th – 16th at the Westin Peachtree Plaza and AmericasMart in Atlanta, GA.
Poster #1998512, titled “Pharmacokinetics of Nalbuphine Hydrochloride Extended Release Tablets in Hemodialysis and Healthy Subjects following Multiple Escalating Oral Doses,” reports results from Trevi’s recently completed Phase 1 trial in renally impaired patients on hemodialysis. The poster’s first author, Amale Hawi, PhD, will be available at the poster on Tuesday, September 16, 2014, from 7:00-8:00 am to discuss the findings.
Thomas Sciascia, MD, Trevi’s co-founder and Chief Medical Officer, said, “Opioids have not historically been well characterized in renally impaired patients. This rigorous study characterized the pharmacokinetics of Nalbuphine ER in renally impaired patients, established that the drug was well tolerated across the entire dose range, and demonstrated the drug is not affected by the dialysis process. We also observed compelling proof-of-concept data in the reduction of itching over the two-week period in the hemodialysis patients. This study was the basis for the pivotal study in patients with moderate to severe uremic pruritus that we initiated this summer.”
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a late-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. Trevi initiated a pivotal trial in uremic pruritus in mid-2014 and expects to report results in the third quarter of 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.
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