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Trevi Therapeutics Reports Positive Results from the Ph2b/3 PRISM Trial of Haduvio™ in the Treatment of Prurigo Nodularis
Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint as measured by a 4-point reduction in the Worst
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint as measured by a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) (p=0.0157)\nThe trial also met key secondary endpoints, with a safety profile consistent with prior studies\nTopline data will be presented by management and study investigator, Jennifer L Parish, MD, on a conference call and webcast on June 29, 2022, at 8:30 am EDT\nNEW HAVEN, Conn., June 29, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis (IPF), today announced positive results from its Phase 2b/3 Pruritus Relief through Itch-Scratch Modulation (PRISM) trial of Haduvio in treating prurigo nodularis.\n\n \n \n \n \n \n \n\n \nTrevi Therapeutics Ph2b/3 PRISM trial of Haduvio achieves statistical significance for the treatment of Prurigo Nodularis\"We are very pleased to announce the statistically significant results for Haduvio from the PRISM trial, the first and only oral therapy to demonstrate in a clinical trial a positive result in treating prurigo nodularis,\" said Jennifer Good, President and CEO of Trevi Therapeutics. \"This positive trial in prurigo nodularis, along with the highly statistically significant data from the interim analysis of our Phase 2 trial in IPF chronic cough that we presented earlier this year, further supports our belief that Haduvio could potentially benefit patients across a broad range of refractory chronic pruritic and cough conditions.\"\nPrurigo nodularis is a chronic disease characterized by severe pruritus and the presence of nodules, lesions, and excoriations. Chronic pruritus is a key contributing cause of prurigo nodularis and manifests in an itch-scratch cycle, which is difficult to disrupt. There are no approved therapies for prurigo nodularis where a large unmet need exists due to its impact on patients' quality of life, function, and emotional well-being.\n\"Prurigo nodularis is one of the most challenging dermatologic diseases for clinicians to manage,\" said Jennifer L Parish, MD, Dermatologist at Parish Dermatology and study investigator for the PRISM trial. \"Patients suffer not only from the i...