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Clinical Trial
. 2020 Jan:215:408-415.
doi: 10.1016/j.schres.2019.07.055. Epub 2019 Aug 27.

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

Nakao Iwata  1 , Jun Ishigooka  2 , Won-Hyoung Kim  3 , Bo-Hyun Yoon  4 , Shih-Ku Lin  5 , Ahmad Hatim Sulaiman  6 , Rowena Cosca  7 , Lina Wang  8 , Yury Suchkov  9 , Alexey Agarkov  10 , Kei Watabe  11 , Tomohito Matsui  11 , Takayuki Sato  11 , Yoshifumi Inoue  12 , Teruhiko Higuchi  13 , Christoph U Correll  14 , John M Kane  15
Affiliations
Free article
Clinical Trial

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

Nakao Iwata et al. Schizophr Res. 2020 Jan.
Free article

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.

Keywords: Adherence; Antipsychotics; Dopamine D(3)-receptor.

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Conflict of interest statement

Declaration of Competing Interest NI reports personal fees from Otsuka, Sumitomo Dainippon, Janssen, Eli Lilly, and Pfizer, grants from Otsuka, Daiichi-Sankyo, outside the submitted work. JI reports grants from Sumitomo Dainippon during the conduct of the study, personal fees from Meiji Seika Pharma, MSD, Astellas, Novartis, Pfizer, Otsuka, Eli Lilly, Takeda, and Eisai, outside the submitted work. WHK reports grants from Sumitomo Dainippon, during the conduct of the study. TH reports personal fees from Meiji Seika Pharma, MSD, Allergan, Eisai, Pfizer, Janssen, Lundbeck, Shionogi, Yoshitomi, Kyowa Hakko Kirin, Mochida, Otsuka, Sumitomo Dainippon, Mitsubishi Tanabe, Eli Lilly, and Takeda, outside the submitted work. CUC reports personal fees from Alkermes, Allergan, Angelini, Boehringer-Ingelheim, Gerson Lehrman Group, Indivior, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Merck, Neurocrine, Noven, Otsuka, Pfizer, Rovi, Servier, Sumitomo Dainippon, Sunovion, Supernus, Takeda, Teva, Bristol-Myers Squibb, and UpToDate, grants from Janssen and Takeda, other from Boehringer-Ingelheim, Lundbeck, Rovi, Supernus, Teva, and LB Pharma, outside the submitted work. JMK reports personal fees from Alkermes, Sumitomo Dainippon, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest (Allergan), Genentech, H. Lundbeck, Intracellular Therapies, Janssen, Johnson and Johnson, LB Pharmaceuticals, Merck, Minerva, Neurocrine, Otsuka, Pierre Fabre, Reviva, Roche, Sunovion, Takeda and Teva, grants from Otsuka, Lundbeck and Janssen, participated in advisory boards for Alkermes, Sumitomo Dainippon, Intracellular Therapies, Lundbeck, Neurocrine, Otsuka, Pierre Fabre, Takeda and Teva, outside the submitted work. JMK is a shareholder in Vanguard Research Group and LB Pharmaceuticals. All other authors declare no competing interests.

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