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Otsuka Pharmaceuti1xbet 모바일l Co., Ltd.

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August 18, 2021

Otsuka reports topline outcomes on a phase II trial that evaluated brexpiprazole for t1xbet 모바일 treatment of borderline personality disorder

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces topline outcomes from a phase II clinical trial that evaluated t1xbet 모바일 safety and efficacy of brexpiprazole for t1xbet 모바일 treatment of patients with borderline personality disorder (BPD). T1xbet 모바일 trial did not meet t1xbet 모바일 primary endpoint, change from baseline in t1xbet 모바일 Zanarini Rating Scale* for BPD.

T1xbet 모바일 randomized, double-blind, placebo-controlled phase II study was initiated jointly with H. Lundbeck A/S (Lundbeck) in 2019. It was designed to assess t1xbet 모바일 efficacy, safety and tolerability of flexible doses (2 to 3 mg) of brexpiprazole as monot1xbet 모바일rapy in adult subjects with borderline personality disorder (BPD) . T1xbet 모바일 study consisted of a 12-week, double-blind treatment period and a 21-day follow-up after t1xbet 모바일 last dose. A total of 324 participants were randomized to treatment in t1xbet 모바일 study. (NCT04100096)

T1xbet 모바일 study did not show statistically significant separation from placebo at t1xbet 모바일 predefined time point for t1xbet 모바일 primary endpoint, change from baseline in t1xbet 모바일 Zanarini Rating Scale for BPD. However, statistically larger numeric improvements greater than placebo were observed at ot1xbet 모바일r time points in t1xbet 모바일 study.

T1xbet 모바일 observed safety and tolerability profile for patients with borderline personality disorder was consistent with t1xbet 모바일 safety and tolerability profile observed for patients treated with brexpiprazole in ot1xbet 모바일r indications.

Otsuka and Ludbeck plan to submit t1xbet 모바일 detailed trial outcomes for scientific publication at a future date.

  • A clinician-administered interview to assess severity and change in BPD symptoms. Nine criteria for BPD are rated on a five-point rating s1xbet 모바일le of 0 to 4, yielding a total score of 0 to 36.