Trevi Therapeutics, Inc. is a late-stage clinical development company 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 significant impairment in quality of life and increased mortality. Prurigo nodularis is an intensely pruritic dermatologic condition characterized by unsightly and itchy skin papules and nodules. There are no approved therapies in the United States or Europe for either condition.
In September 2015, Trevi announced positive study results from a Phase 2/3 trial conducted in approximately 370 patients with moderate to severe uremic pruritus. The study included patients in the U.S. and Europe, and was 8 weeks in duration. Patients receiving the 120 mg dose of Nalbuphine® ER (n=120) experienced a 3.5 point reduction in itch intensity from baseline, resulting in a highly statistically significant mean reduction in itch intensity as compared to placebo (p-value=0.017).
In October 2016, Trevi announced positive study results from an eight week Phase 2 trial conducted in 63 patients with moderate to severe prurigo nodularis. The proportion of patients in the Nalbuphine® ER 180 mg BID arm meeting 50% responder criteria at week 10 or last observed visit (MITT population with n=18) approached statistical significance (p=0.083), and this arm met statistical significance for patients (n=12) completing treatment (p=0.028). Change from baseline in the ItchyQoL™ total score (22 questions that measure how pruritus affects a patient’s quality of life), was significantly more favorable for the Nalbuphine® ER 180 mg BID dose compared to placebo (p=0.022).
Founded in 2011, Trevi is headquartered in New Haven, CT.
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