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 40â¯mg, blonanserin 80â¯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 40â¯mg (nâ¯=â¯196), blonanserin 80â¯mg (nâ¯=â¯194), or placebo (nâ¯=â¯190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6â¯weeks (least square mean [LSM] difference vs placebo: -5.6 with blonanserin 40â¯mg; 95% confidence interval [CI] -9.6, -1.6; adjusted pâ¯=â¯0.007, andâ¯-â¯10.4 with blonanserin 80â¯mg; 95% CI -14.4, -6.4; adjusted pâ¯<â¯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.