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

Research output: Contribution to journalArticle

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
JournalSchizophrenia Research
DOIs
Publication statusAccepted/In press - 01-01-2019

Fingerprint

Transdermal Patch
Multicenter Studies
Schizophrenia
Placebos
Safety
blonanserin
Confidence Intervals
Psychomotor Agitation
Sleep Initiation and Maintenance Disorders
Tremor
Erythema
Pruritus
Least-Squares Analysis
Double-Blind Method
Antipsychotic Agents
Therapeutics
Pharmacokinetics

All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

Iwata, Nakao ; Ishigooka, Jun ; Kim, Won Hyoung ; Yoon, Bo Hyun ; Lin, Shih Ku ; Sulaiman, Ahmad Hatim ; Cosca, Rowena ; Wang, Lina ; Suchkov, Yury ; Agarkov, Alexey ; Watabe, Kei ; Matsui, Tomohito ; Sato, Takayuki ; Inoue, Yoshifumi ; Higuchi, Teruhiko ; Correll, Christoph U. ; Kane, John M. / Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia : A 6-week randomized, double-blind, placebo-controlled, multicenter study. In: Schizophrenia Research. 2019.
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title = "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.",
author = "Nakao Iwata and Jun Ishigooka and Kim, {Won Hyoung} and Yoon, {Bo Hyun} and Lin, {Shih Ku} and Sulaiman, {Ahmad Hatim} and Rowena Cosca and Lina Wang and Yury Suchkov and Alexey Agarkov and Kei Watabe and Tomohito Matsui and Takayuki Sato and Yoshifumi Inoue and Teruhiko Higuchi and Correll, {Christoph U.} and Kane, {John M.}",
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Iwata, N, Ishigooka, J, Kim, WH, Yoon, BH, Lin, SK, Sulaiman, AH, Cosca, R, Wang, L, Suchkov, Y, Agarkov, A, Watabe, K, Matsui, T, Sato, T, Inoue, Y, Higuchi, T, Correll, CU & Kane, JM 2019, 'Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study', Schizophrenia Research. https://doi.org/10.1016/j.schres.2019.07.055

Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia : A 6-week randomized, double-blind, placebo-controlled, multicenter study. / Iwata, Nakao; Ishigooka, Jun; Kim, Won Hyoung; Yoon, Bo Hyun; Lin, Shih Ku; Sulaiman, Ahmad Hatim; Cosca, Rowena; Wang, Lina; Suchkov, Yury; Agarkov, Alexey; Watabe, Kei; Matsui, Tomohito; Sato, Takayuki; Inoue, Yoshifumi; Higuchi, Teruhiko; Correll, Christoph U.; Kane, John M.

In: Schizophrenia Research, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia

T2 - A 6-week randomized, double-blind, placebo-controlled, multicenter study

AU - Iwata, Nakao

AU - Ishigooka, Jun

AU - Kim, Won Hyoung

AU - Yoon, Bo Hyun

AU - Lin, Shih Ku

AU - Sulaiman, Ahmad Hatim

AU - Cosca, Rowena

AU - Wang, Lina

AU - Suchkov, Yury

AU - Agarkov, Alexey

AU - Watabe, Kei

AU - Matsui, Tomohito

AU - Sato, Takayuki

AU - Inoue, Yoshifumi

AU - Higuchi, Teruhiko

AU - Correll, Christoph U.

AU - Kane, John M.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

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U2 - 10.1016/j.schres.2019.07.055

DO - 10.1016/j.schres.2019.07.055

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