Proof-of-concept study with pharmacokinetics demonstrates
anti-pruritic activity of oral nalbuphine ER in hemodialysis patients
with uremic pruritus
NEW HAVEN, Conn.--(BUSINESS WIRE)--
Therapeutics, Inc. (“Trevi”), a clinical stage biotechnology company
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.
Trevi Therapeutics, Inc.
Source: Trevi Therapeutics, Inc.