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, Yasuhiro; Higuchi, Tetsuya; Correll, Christoph U.; Kane, John M.

doi:10.1016/j.schres.2019.07.055

Cited by 31 publications

(43 citation statements)

References 24 publications

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Section: Introductionmentioning

confidence: 99%

“…In 2019, the blonanserin patch (BLO-P) was approved for the treatment of schizophrenia in Japan [14]. This was the world's first formulation of a transdermal patch to administer an antipsychotic [14]. The medication status of BLO-P is easy to check by visual inspection, and daily dermal application has been shown to maintain a stable drug concentration in the blood for 24 h [14].…”

Section: Introductionmentioning

confidence: 99%

“…This was the world's first formulation of a transdermal patch to administer an antipsychotic [14]. The medication status of BLO-P is easy to check by visual inspection, and daily dermal application has been shown to maintain a stable drug concentration in the blood for 24 h [14]. Transdermal drug delivery avoids the problems associated with gastrointestinal incompatibility and the effects of hepatic first-pass metabolism, without the unpleasant and painful experience of injections [15].…”

Section: Introductionmentioning

confidence: 99%

“…Transdermal drug delivery avoids the problems associated with gastrointestinal incompatibility and the effects of hepatic first-pass metabolism, without the unpleasant and painful experience of injections [15]. The patch can be hidden under clothing and may be a better option for patients who are embarrassed to be seen taking tablets or attending a clinic for injections [14]. A further advantage of the use of a patch for drug delivery is greater control for the patient over medication self-administration [16].…”

Section: Introductionmentioning

confidence: 99%

“…Various antipsychotics have been approved for schizophrenia treatment in Japan; however, the only antipsychotic medications for which there have been 6-week, double-blind, randomized, placebo-controlled trials as phase 3 trials in Japan are asenapine (ASE) [17], BLO-P [14], brexpiprazole (BRE) [18], and paliperidone extended-release (PAL-ER) [19]. All of these were included in the review.…”

Section: Introductionmentioning

confidence: 99%

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Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

et al. 2020

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Introduction The use of the blonanserin patch (BLO-P) for schizophrenia treatment was approved in Japan in 2019. This systematic review of trials in Japan assessed the efficacy and safety profile of BLO-P compared with other antipsychotics. Methods The systematic review included 6-week, double-blind, randomized, placebo-controlled, phase 3 trials in Japan that included patients with acute schizophrenia. Pooled data for patients receiving BLO-P 40 and 80 mg/day (BLO-P40+80) were compared with pooled data for patients receiving asenapine 10 and 20 mg/day (ASE10+20) and data for those receiving brexpiprazole 2 mg/day (BRE2) and paliperidone extended-release 6 mg/day (PAL-ER6). Results All the investigated treatments were superior to placebo in reducing the Positive and Negative Syndrome Scale (PANSS) total score; the Hedges’ g values (95% confidence interval) for BLO-P40+80, ASE10+20, BRE2, and PAL-ER6 were−0.40 (−0.58,−0.22),−0.61 (−0.79,−0.42),−0.33 (−0.60,−0.07), and−0.69 (−0.93,−0.45), respectively. There were differences among the antipsychotics in the incidence of various individual adverse events. Discussion BLO-P40+80 may have a good efficacy/safety/tolerability profile for the treatment of patients with acute schizophrenia.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

et al. 2020

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Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline

Matsushima,

Otsubo,

Aoi

et al. 2024

Clin Pharma and Therapeutics

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To further our understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline and promote effective implementation, a public workshop was held in Japan by regulatory agency and industry representatives. In this workshop, important concepts explained in the ICH E17 guideline, such as intrinsic/extrinsic ethnic factors that influence treatment effects (“effect modifiers”) and the holistic evaluation of consistency of treatment effect were actively discussed through case studies. The importance of holistic evaluation of consistency was recognized, and it was concluded that the evaluation and relevant discussion should be shared with regulatory authorities, sponsors, and broader stakeholders.

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Pharmacokinetic Evaluation of Blonanserin Transdermal Patch: Population Analysis and Simulation of Plasma Concentration and Dopamine D₂ Receptor Occupancy in Clinical Settings

Kitamura

Takagaki

Nemoto

et al. 2021

The Journal of Clinical Pharma

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Blonanserin is an atypical antipsychotic drug with high affinity and selective antagonism for dopamine D2 and D3 and serotonin 5‐HT2A receptors. Blonanserin transdermal patch is the first transdermal formulation developed for the treatment of schizophrenia. The purpose of this population pharmacokinetic (PPK) analysis was to evaluate the characteristics of blonanserin pharmacokinetics after transdermal patch application, to estimate the daily fluctuation in blonanserin plasma concentration, and to evaluate the impact of patch application noncompliance to support usage in clinical settings. A total of 3747 plasma blonanserin concentrations from 9 clinical studies (93 healthy volunteers and 348 patients with schizophrenia) were used in the PPK analysis. The plasma concentration was predicted using the final PPK model, and dopamine D2 receptor occupancy was estimated on the basis of the results of a separately reported positron emission tomography study. A 2‐compartment, parallel zero‐order absorption with a lag time and first‐order elimination model was developed to describe the pharmacokinetics of blonanserin, including the change in absorption rate during patch application. The maximum/minimum ratio of plasma concentration was estimated as 1.10 at steady state, indicating minimal fluctuation. In the case of failure to remove the previous patch or a missing application, the increase or decrease in plasma concentration and dopamine D2 receptor occupancy was <20%. These results indicated that the plasma blonanserin concentration and dopamine D2 receptor occupancy were stable after blonanserin transdermal patch application, which may lead to improved tolerability during the treatment of patients with schizophrenia.

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

Cited by 31 publications

References 24 publications

Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline

Pharmacokinetic Evaluation of Blonanserin Transdermal Patch: Population Analysis and Simulation of Plasma Concentration and Dopamine D₂ Receptor Occupancy in Clinical Settings

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

Cited by 31 publications

References 24 publications

Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline

Pharmacokinetic Evaluation of Blonanserin Transdermal Patch: Population Analysis and Simulation of Plasma Concentration and Dopamine D2 Receptor Occupancy in Clinical Settings

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Resources

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Pharmacokinetic Evaluation of Blonanserin Transdermal Patch: Population Analysis and Simulation of Plasma Concentration and Dopamine D₂ Receptor Occupancy in Clinical Settings