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

Translated title of the contribution: Safety and Tolerability of Repeated Application of Blonanserin Transdermal Patch(DSP-5423P)in Patients with Schizophrenia

Osamu Takashio, Taigi Yamazaki, Minako Mano, Sachiko Yokoyama, Masami Hida, Toshiaki Tsuneoka, Bun Yamagata, Genshin Minegishi, Hironori Nishibe, Mizuki Horiuchi, Kenji Shirakura, Takehiko Sambe, Hiroki Yamada, Naoki Uchida, Shinichi Kobayashi, Akira Iwanami

Research output: Contribution to journalArticlepeer-review

Abstract

DSP-5423P(DSP)is a transdermal delivery formulation containing 20 mg of blonanserin per 40 cm2 patch. This open-label, for nearly 2 weeks equivalentsingle-arm in 8 patients striatumstudy with dopaminewas schizophrenia. conductedD2 receptorto Four evaluateoccupancy patches the of safety DSP to oral per andadministration day tolerability (80 mg/day ofofrepeated of 16 blonanserin mg/dayapplicationof ) 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).

Translated title of the contributionSafety and Tolerability of Repeated Application of Blonanserin Transdermal Patch(DSP-5423P)in Patients with Schizophrenia
Original languageJapanese
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume51
Issue number5
DOIs
Publication statusPublished - 2020 Oct

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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