Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study.
Nakao Iwata, Jun Ishigooka, Won-Hyoung Kim, Bo-Hyun Yoon, Shih-Ku Lin, Ahmad Hatim Sulaiman, Rowena Cosca, Lina Wang, Yury Suchkov, Alexey Agarkov, Kei Watabe, Tomohito Matsui, Takayuki Sato, Yoshifumi Inoue, Teruhiko Higuchi, Christoph U Correll, John M Kane
Schizophrenia research 2020 JanBlonanserin is a second-generation antipsychotic 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. 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). 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 [LSM] 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. Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability. Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.
Citation
Nakao Iwata, Jun Ishigooka, Won-Hyoung Kim, Bo-Hyun Yoon, Shih-Ku Lin, Ahmad Hatim Sulaiman, Rowena Cosca, Lina Wang, Yury Suchkov, Alexey Agarkov, Kei Watabe, Tomohito Matsui, Takayuki Sato, Yoshifumi Inoue, Teruhiko Higuchi, Christoph U Correll, John M Kane. Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study. Schizophrenia research. 2020 Jan;215:408-415
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PMID: 31471246
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