aripiprazole/sertraline (ASC-01) / Otsuka - LARVOL DELTA

Otsuka and Lundbeck to showcase safety and efficacy data in treatments for challenging mental health conditions (Businesswire) - “Otsuka…and Lundbeck…announced upcoming data presentations reinforcing the long-term safety and efficacy of brexpiprazole for the adjunctive treatment of major depressive disorder (MDD) and treatment of schizophrenia as well as presentations regarding additional analyses of the long-term efficacy and safety of aripiprazole once-monthly injection as maintenance monotherapy treatment of bipolar I disorder in adult patients. The Otsuka and Lundbeck alliance will showcase eight data presentations, including two long-term studies, at the upcoming Psych Congress, which will be held in New Orleans from September 16-19, 2017.”

Clinical data • CNS Disorders • Schizophrenia

Otsuka: FY2015 Financial Results (Otsuka) - Anticipated NDA submission in Japan for major depressive disorder in 2016

Anticipated Japanese regulatory • Depression

A randomized, double-blind comparison of aripiprazole/sertraline combination and placebo/sertraline combination in patients with major depressive disorder. (PubMed, Psychiatry Clin Neurosci) - "In patients with MDD who showed an inadequate response to treatment with sertraline 100 mg/day, ASC was efficacious and well tolerated."

Clinical • Journal