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

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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.

Original languageEnglish
Pages (from-to)408-415
Number of pages8
JournalSchizophrenia Research
Volume215
DOIs
Publication statusPublished - 01-2020

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All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

Iwata, N., Ishigooka, J., Kim, W. H., Yoon, B. H., Lin, S. K., Sulaiman, A. H., Cosca, R., Wang, L., Suchkov, Y., Agarkov, A., Watabe, K., Matsui, T., Sato, T., Inoue, Y., Higuchi, T., Correll, C. U., & Kane, J. M. (2020). Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study. Schizophrenia Research, 215, 408-415. https://doi.org/10.1016/j.schres.2019.07.055