Trevi Therapeutics announced statistically significant results from its Phase 2/3 trial of Nalbuphine ER for the treatment of moderate to severe uremic pruritus. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality, and currently has no approved therapies in the United States or Europe.

The Phase 2/3 study is a multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm trial evaluating the safety and anti-pruritic efficacy of Nalbuphine ER tablets dosed twice-daily at 60mg and 120mg in approximately 370 patients on hemodialysis. The study enrolled patients with a wide range of mean moderate-to-severe itch intensity, ranging from 4.5 to 10 on the ten-point Numerical Rating Score (NRS) scale.

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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=0.017). A statistically significant mean reduction 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. On average, patients entered the study with a baseline mean NRS itch score of 6.9 (just under severe NRS score of 7), and at the end of the 8th week dosing period, average itch scores had been reduced to an NRS score of 3.4, which is considered mild on the NRS scale. Severe itch patients (those with NRS scores ≥7) experienced on average an NRS score reduction of 4.5 points from baseline (P=0.007). The 60mg dose showed a numerically favorable reduction over placebo, but did not achieve statistical significance.

Nalbuphine ER is an oral extended-release opioid with a dual mechanism of action, mu receptor antagonist and kappa receptor agonist, both of which have been shown in research to be effective in abolishing itch.

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