Trevi Therapeutics Completes Enrollment for Haduvio Study

Trevi Therapeutics, a clinical-stage biopharmaceutical company, has completed enrollment in its phase 2b/3 PRISM study investigating nalbuphine ER (Haduvio; Trevi Therapeutics) as a treatmentofchronic pruritus in prurigo nodularis (PN). The study is expected to have data reported by the second quarter of 2022.

"We are pleased to have completed enrollment in our phase 2b/3 PRISM trial and look forward to reporting top-line data in the second quarter of this year," said Jennifer Good, president and CEO. "This is an important milestone in the development of Haduvio which is the lead oral compound in clinical development for pruritus in PN and which we believe may offer an important treatment option to these seriously impacted patients. By targeting the pruritus associated with prurigo nodularis, Haduvio is designed to break the itch-scratch cycle which has a significant impact on patients' quality of life. We look forward to seeing these results and advancing the development of Haduvio to address the unmet need of patients with pruritus across conditions."

The PRISM trial (NCT03497975) is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of nalbuphine ER for severe pruritus in patients with PN, according to the release. The patients will be randomized between 2 treatment groups, oral Haduvio162 mg or placebo, twice daily including an initial 2-week blinded titration period.

In the trial, subjects are randomized equally across two treatment groups—oral nalbuphine ER 162-mg or placebo—equally. Each treatment group will be take medication twice daily and includean initial 2-week blinded titration period. The primary endpoint of the trial is the proportion of patients achieving a greater than or equal to 4-point improvement in the weekly mean Worst Itch Numerical Rating Scale (WI-NRS) score at Week 14 compared to baseline.

In May of 2021, the FDAgranted Fast Track designation of nalbuphine ER for the proposed indication of reduction of moderate to severe pruritus in patients with PN.

Reference:

1. Trevi therapeutics completes enrollment for phase 2b/3 prism study in chronic pruritus in pn. BioSpace. Published February 1, 2022Accessed February 1, 2022. https://www.biospace.com/article/trevi-therapeutics-completes-enrollment-for-phase-2b-3-prism-study-in-chronic-pruritus-in-pn/