Trevi Therapeutics announces 52-week results from Phase 2b/3 PRISM study

Trevi Therapeutics announced the 52-week results from its phase 2b/3 PRISM open-label extension study of Haduvio for the treatment of prurigo nodularis. The data was presented by Professor Elke Weisshaar on October 13th at the European Academy of Dermatology & Venereology Congress 2023 in Berlin, Germany. “We are pleased with the results from our preliminary analyses of our OLE data supporting the safety profile of nalbuphine ER up to 52 weeks which were presented at EADV today,” said Jennifer Good, President and CEO of Trevi Therapeutics. “The long-term data also supports the continued effectiveness of Haduvio in reducing itch over 52 weeks for the participants who remained in the study. We are preparing for an end of phase 2 meeting with the FDA to discuss next steps in development for this program.” 151 subjects completed the open-label extension, adding to the safety database for Haduvio. The safety data were generally consistent with the safety profile of Haduvio observed in the 14-week portion of PRISM and previous trials of Haduvio. Adverse events reported with a frequency greater than 5% in the 38-week open-label period included nausea, dizziness, vomiting, fatigue, and somnolence. Study discontinuation due to adverse events occurred in 13% of subjects during the open-label period, and serious adverse events were reported for 13 subjects, although only 2 of these events were considered potentially treatment related.