Benzinga | Jul 13, 2020 07:34AM EDT

Trevi Therapeutics Announces Independent Data Monitoring Committee Recommends Continuation Of PRISM Trial With Expansion To 360 Subjects Per The Adaptive Design

Independent Data Monitoring Committee Recommends Continuation of PRISM Trial with Expansion to 360 Subjects per the Adaptive Design

Enrollment Expected to be Complete by Third Quarter 2021

Introducing HADUVIO(tm) as Proposed Trade Name for Nalbuphine ER

NEW HAVEN, Conn., July 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the completion of the pre-specified sample size re-estimation (SSRE) analysis for the ongoing PRISM Phase 2b/3 trial of Haduvio for severe pruritus in patients with prurigo nodularis (PN).

Based on the SSRE analysis the independent Data Monitoring Committee (DMC) recommended that the PRISM trial should continue and that the trial size should increase from an initial enrollment target of 240 to 360 subjects which maintains the statistical power for the primary endpoint. The DMC's recommendation was based on a pre-specified interim conditional power assessment conducted after approximately 45% of the initial targeted number of patients were evaluable for the primary endpoint of the trial. Based on the DMC's recommendation, the Company plans to increase the size of the trial to 360 subjects.

"Severe pruritus in prurigo nodularis is a very serious and difficult-to-treat condition. We are pleased with the re-estimation results midway through the trial which inform the sample size and further reinforces our view that Haduvio may be an effective treatment option for patients with PN," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "Enrollment in the PRISM trial has been picking up nicely since the removal of most COVID-19 screening and enrollment restrictions. We have increased the number of active sites to more than 60 globally and approximately 140 subjects have enrolled in the study. Based on the increased sample size, and considering COVID-19 related restrictions, we expect to complete enrollment in the third quarter of 2021 and report top-line data in the fourth quarter of 2021."