FDA approves REXULTI to treat depression and schizophrenia

WASHINGTON - July 14, 2015 - PRLog -- Otsuka Pharmaceuticals and Lundbeck have received approval from the U.S. Food and Drug Administration (FDA) for REXULTI® (brexpiprazole) to be used as an adjunctive therapy to treat adult patients with major depressive disorder (MDD) and to treat schizophrenia in adults.

REXULTI® was assessed in 4,300 patients in phase II and III clinical trials and FDA approval stemmed from four completed placebo-controlled clinical phase III studies. REXULTI was used as an adjunctive therapy to antidepressants in MDD and was revealed to be superior to the placebo. REXULTI was evaluted in two studies to treat schizophrenia and results confirmed the drug demonstrated statistically significant efficacy for the primary endpoint of PANSS (Positive and Negative Syndrome Scale).

Rexulti will be co-marketed by both Otsuka and Lundbeck and is expected to hit the U.S. market in August 2015. Industry analysts predict the drug will rake in annual sales of $1.4 billion by 2020.

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