Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study
Document Type
Article
Publication Date
1-1-2020
Abstract
Background: Blonanserin is a second-generation antipsychofic used for the treatment of schizophrenia.This study determined the efficacy, safety and pharmacokinetics of a blonanserin transdermal patch in patients with acutely exacerbated schizophrenia. Methods: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190): of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean LW] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p < 0.001). Blonanserin was well tolerated; the most common TEAEs reported were application-site erythema and pruritus, akathisia, tremor, and insomnia. Conclusions: Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability. (C) 2019 The Authors. Published by Elsevier B.V.
Keywords
Dopamine D-3-receptor, Antipsychotics, Adherence
Divisions
psychological
Funders
Sumitomo Dainippon Pharma Co., Ltd.
Publication Title
Schizophrenia Research
Volume
215
Publisher
Elsevier
Publisher Location
RADARWEG 29, 1043 NX AMSTERDAM, NETHERLANDS