Phase II trial for brexpiprazole in borderline personality disorder misses goals

Otsuka Pharmaceutical (TYO: 4578) yesterday announced top-line outcomes from a Phase II clinical trial that evaluated the safety and efficacy of brexpiprazole for the treatment of patients with borderline personality disorder (BPD), that did not meet the primary endpoint, change from baseline in the Zanarini Rating Scale for BPD.

The randomized, double-blind, placebo-controlled Phase II study was initiated jointly with Denmark’s Lundbeck (LUND: CO), which markets the oral antipsychotic drug under the Rexulti trade name, in 2019. Lundbeck shares closed down 6.9% at 184.45 Danish kroner following the news yesterday.

It was designed to assess the efficacy, safety and tolerability of flexible doses (2mg to 3mg) of brexpiprazole as monotherapy in adult subjects with borderline personality disorder (BPD). The study consisted of a 12-week, double-blind treatment period and a 21-day follow-up after the last dose. A total of 324 participants were randomized to treatment in the study. (NCT04100096）