Study will enroll 360 patients in the United States and Europe
NEW HAVEN, Conn.--(BUSINESS WIRE)--
Therapeutics, Inc. (“Trevi” or the “Company”), a clinical stage
biotechnology company developing Nalbuphine
ER for chronic pruritus conditions, today announced the first
patient enrolled in the pivotal study of Nalbuphine ER in hemodialysis
patients with uremic
pruritus. The Company recently released data from its successfully
completed Phase 1 trial in which Nalbuphine ER was well tolerated in
hemodialysis patients and established proof-of-concept for Nalbuphine ER
in treating uremic pruritus.
Jennifer L. Good, Trevi’s President and Chief Executive Officer, said,
“Approximately 40% of hemodialysis patients have moderate to severe
pruritus that significantly impacts their quality of life. There are no
approved therapies for this condition. The initiation of this pivotal
study of Nalbuphine ER is a significant step forward in the development
of a potential therapeutic treatment option for these patients.”
Thomas R. Sciascia, M.D., Trevi’s Chief Medical Officer, said, “There
has been a significant amount of research done over a number of years
hypothesizing that the mu antagonist/kappa agonist mechanism could be a
good treatment option for patients suffering from chronic pruritus. This
study is an important step in advancing the research that has been done
around the world in chronic pruritus.”
The multi-center, randomized, double-blind, placebo-controlled,
parallel, three-arm study will evaluate the safety and anti-pruritic
efficacy of Nalbuphine ER tablets in approximately 360 hemodialysis
patients. The study will be conducted in the United States and Europe.
The primary endpoint for the study will measure the change from worst
itch at baseline in patients with moderate to severe uremic pruritus,
treated with two doses of Nalbuphine ER. The study also includes other
secondary endpoints, including patient perception of the burden of itch,
quality of life effects of pruritus, and impact on sleep, anxiety and
The study will consist of a titration period of two weeks, followed by a
six week blinded period on a fixed dose of drug or placebo and a
wash-out period. At the end of the wash-out period, patients may be
eligible to roll over into a six month open label extension study. The
Company expects topline data from this study in the fourth quarter of
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
Founded in 2011, Trevi is headquartered in New Haven, CT.
For additional information, visit www.trevitherapeutics.com.
Trevi Therapeutics, Inc.
Laura Brophy, 203-331-7618
Source: Trevi Therapeutics, Inc.