Positive data from Phase II/III trial of Nalbuphine ER in uremic pruritus-Trevi Therapeutics

Trevi Therapeutics announced statistically significant results from its oral Nalbuphine ER Phase II/III trial for the treatment of moderate to severe uremic pruritus. The multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study evaluated the safety and anti-pruritic efficacy of Nalbuphine ER tablets dosed twice-daily at 60mg and 120mg in approximately 370 patients on hemodialysis in the United States and Europe.

Patients receiving 120 mg 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). A statistically significant mean reduction for Nalbuphine ER compared to placebo was observed as early as one week following titration to the Nalbuphine ER fixed dose, and there was a statistically significant separation from placebo throughout the remaining blinded period.

The secondary endpoints, the Skindex-10 Disease Domain and the Itch MOS Sleep index, provided confirmatory evidence of a favorable Nalbuphine ER effect on itching compared to placebo. Only one serious adverse event was attributed to the drug in the study, with the most common adverse events being nausea, vomiting, dizziness and somnolence. The Company expects the open label extension study to be completed by year-end.