統合失調症患者におけるブロナンセリン経皮吸収型製剤(DSP-5423P) 2 週間反復貼付時の忍容性と安全性

DSP-5423P(DSP)is a transdermal delivery formulation containing 20 mg of blonanserin per 40 cm² patch. This ^open-label, for _nearly 2 weeks _equivalent^single-arm in 8 patients _striatum^study with _dopamine^was schizophrenia. ^conducted_{D2 receptor}^to Four ^evaluate_occupancy patches ^the of ^safety DSP _{to oral} per ^and_{administration} day ^tolerability (80 mg／day ^of_of^repeated of ₁₆ blonanserin _mg／day^application_of ) _blonanserin, , possessing ^of DSP were applied to the upper back of the patient once per day for 2 weeks. Adverse events(AEs)and pharmacokinetics and schizophrenia rating scales(PANSS and CGI-S)were used to evaluate safety. AEs were reported in 7 out of 8 cases, with application site erythema(n＝5)the most common, followed by application site pruritus(n＝3), and akathisia(n＝3). No serious AEs occurred, and all AEs were determined to be mild in severity. Extrapyramidal AEs were reported in 4 cases, including akathisia(n＝3), bradykinesia(n＝2), and tremor(n＝1). Adverse drug reactions related to the application site occurred in 5 cases; however, all patients recovered with or without treatment with topical agents and completed the study. No apparent change was found in the Drug Induced Extra-Pyramidal Symptoms Scale total score during the study. Regarding pharmacokinetics, plasma concentration of blonanserin and its metabolites did not show any significant changes after application of DSP. Changes in PANSS and CGI-S scores revealed no worsening of schizophrenia during the study. This study demonstrated that there were no safety or tolerability issues with 2 weeks' administration of DSP.(Trial No. JapicCTI-142423).