Business
Trevi Therapeutics Announces First Quarter 2021 Financial Results and Business Update
Phase 2b/3 PRISM (Chronic Pruritus in PN) Trial Over 70% Enrolled Phase 2 CANAL (Chronic Cough in IPF) Trial Resumes Screening at Multiple Sites Fast Track
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Phase 2b/3 PRISM (Chronic Pruritus in PN) Trial Over 70% Enrolled\n Phase 2 CANAL (Chronic Cough in IPF) Trial Resumes Screening at Multiple Sites\n Fast Track Designation Granted by FDA for Moderate to Severe Pruritus in Prurigo Nodularis (PN)\n\n\nNEW HAVEN, Conn., May 13, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended March 31, 2021, as well as business updates. \n\n \n \n \n \n \n \n\n \nFast Track Designation Granted by FDA for Moderate to Severe Pruritus in Prurigo Nodularis (PN)\"We continue to make progress in our clinical development programs for the treatment of chronic pruritus in patients with PN and chronic cough in patients with Idiopathic Pulmonary Fibrosis (IPF),\" said Jennifer L. Good, President and CEO of Trevi Therapeutics. \"Our PRISM trial is over 70% enrolled and we expect to complete enrollment in the second half of this year. We also recently received FDA Fast Track designation for moderate to severe pruritus in PN, evidencing the seriousness of this condition. In addition, our CANAL trial has resumed screening subjects since the COVID-19 shelter in place directive was lifted at the end of March in the UK and we are very pleased to see screening activity resume. We remain focused on completing enrollment in both trials and planning for the next steps in clinical development,\" concluded Ms. Good.\nKey Business Updates\nPhase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with mild to severe prurigo nodularis: The PRISM trial has enrolled approximately 255 out of the planned 360 total subjects in the trial. We expect to complete enrollment in the second half of 2021, with top-line data to be reported approximately four months after enrollment is complete. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nalbuphine ER for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can re...