Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study.

Abstract

BACKGROUND:

Blonanserin 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.

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 [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.

CONCLUSIONS:

Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability.

• Authors: 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
• Journal: Schizophrenia research (Schizophr Res) Vol. 215 Pg. 408-415 (01 2020) ISSN: 1573-2509 [Electronic] Netherlands
• PMID: 31471246 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antipsychotic Agents
• Piperazines
• Piperidines
• blonanserin

Topics

• Acute Disease
• Adult
• Antipsychotic Agents (administration & dosage, adverse effects, pharmacology)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Piperazines (administration & dosage, adverse effects, pharmacology)
• Piperidines (administration & dosage, adverse effects, pharmacology)
• Psychiatric Status Rating Scales
• Schizophrenia (drug therapy, physiopathology)
• Transdermal Patch