Efficacy and Safety of Oral Nalbuphine Extended Release in Prurigo Nodularis: Results of a Phase 2, Randomized, Controlled Trial with an Open Open-Label Extension Phase

Abstract

• The findings of this study indicate that in patients with PN, NAL-ER tablets, at a dose of 162 mg b.i.d., appear to have a measurable antipruritic effect for patients who successfully maintain the initial therapy for at least 10 weeks. • The significantly greater response rate for NAL-ER 162 mg patients who completed the full 10 weeks of double-blind treatment compared with placebo is consistent with a clinical benefit that requires compliance with the designated dosing schedule and duration. • Further evaluation of NAL-ER, including further elucidation of its underlying mechanism of action, is thus warranted in this difficult-to-treat disease, with a larger phase 2b/3 clinical trial currently evaluating the 162 mg b.i.d. dose. Efficacy and Safety of Oral Nalbuphine Extended Release in Prurigo Nodularis: Results of a Phase 2, Randomized, Controlled Trial with an Open-Label Extension Phase Elke Weisshaar1; Thomas R. Sciascia2; Sonja Ständer3 1Occupational Dermatology, Department of Dermatology, University Hospital, Heidelberg, Germany; 2Trevi Therapeutics, New Haven, CT, USA; 3Department of Dermatology and Center for Chronic Pruritus, University Hospital, Münster, Germany