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

Abstract

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.

Efficacy, tolerability, and safety of lurasidone for acute schizophrenia: A systematic review and network meta‐analysis of phase 3 trials in Japan

“…Another reasons might be that the placebo response of LUR's DBRPCP3Ts was large compared with those of other antipsychotic's DBRPCP3Ts. 16 Although there was no significant difference in the primary outcome between LUR40 and LUR80, the effect size of LUR40 seems to be larger than that of LUR80. Dose-response meta-analysis of antipsychotic drugs for acute schizophrenia showed that the 95% effective dose of lurasidone was 147 mg/d.…”

“…The failure of these two DBRPCP3Ts 1,2 might be due to a type II error (ie, low statistical power). Another reasons might be that the placebo response of LUR’s DBRPCP3Ts was large compared with those of other antipsychotic's DBRPCP3Ts 16 . Although there was no significant difference in the primary outcome between LUR40 and LUR80, the effect size of LUR40 seems to be larger than that of LUR80.…”

Use of Blonanserin Transdermal Patch in Home Treatment of Schizophrenia

“…The efficacy of the BTP (both 40 and 80 mg) is significantly superior to that of a placebo, improving positive and negative syndrome scale scores like other medications such as asenapine, brexpiprazole, and paliperidone extended release. 7 The BTP is associated with risks, including more severe extrapyramidal symptoms, compared with a placebo. However, the risk of weight gain with the BTP is lowest among these drugs.…”

“…The BTP was the first patch-type drug in the psychiatric field and has been used in clinical practice since 2019. The efficacy of the BTP (both 40 and 80 mg) is significantly superior to that of a placebo, improving positive and negative syndrome scale scores like other medications such as asenapine, brexpiprazole, and paliperidone extended release 7 . The BTP is associated with risks, including more severe extrapyramidal symptoms, compared with a placebo.…”

“…The BTP is associated with risks, including more severe extrapyramidal symptoms, compared with a placebo. However, the risk of weight gain with the BTP is lowest among these drugs 7 . From a pharmacokinetic point of view, a patch formula allows the avoidance of first-pass metabolism, which affects oral formulae, providing a stable drug concentration in the blood 8 .…”