Brexpiprazole Phase III results for adjunctive therapy in Major Depressive Disorder- Otsuka + Lundbeck

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced the presentation of Phase III study results evaluating the efficacy of investigational compound brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in a poster presentation, Efficacy and Safety of Adjunctive Brexpiprazole (OPC-34712) in Major Depressive Disorder: Results of Two Pivotal Clinical Studies."

In both studies, key findings included: 1.Adjunctive brexpiprazole showed greater improvement than adjunctive placebo in MADRS total score at Week 6 in the efficacy population per final protocol in Study 1 (2mg+ADT [N=175]: -3.21, p=0.0002), and in Study 2 (1mg+ADT [N=211]: -1.30, p=0.0737; 3mg+ADT [N=213]: -1.95, p=0.0079). Similar results were observed for the efficacy population in both studies. 2. The completion rate was high (greater than 90%) and comparable across brexpiprazole and placebo groups. Discontinuations due to adverse events were low across all groups (1mg = 1.3%, 2mg = 3.2%, 3mg = 3.5%, placebo = 0.7%) and only one patient discontinued due to lack of efficacy (in the brexpiprazole 1mg group). 3.All doses of adjunctive brexpiprazole resulted in notably low levels of sedating or activating side effects. 4.The most frequent adverse events (incidence greater than 5% in any group and more than twice the incidence in the placebo group across the two studies) included akathisia (4.4%, 7.4%, 13.5% vs.1.7%), weight increase (6.6%, 8.0%, 5.7% vs. 1.9%), tremor (4.0%, 2.1%, 5.2% vs. 2.2%) somnolence (4.0%, 4.3%, 5.7% vs. 0.5%) and nasopharyngitis (6.6%, 1.1%. 3.1% vs. 1.7%), in the brexpiprazole 1mg+ADT (N=226), 2mg+ADT (N=188), 3mg+ADT (N=229) versus combined placebo + ADT groups (N=411), respectively.