FDA approves Rexulti (brexpiprazole) for adults with major depressive disorder and with schizophrenia- Lundbeck/Otsuka

Lundbeck and Otsuka Pharmaceutical Co announced that the FDA approved Rexulti (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia. Rexulti was studied in more than 4,300 subjects in phase II and III clinical trials, and the approval was supported by four completed placebo-controlled clinical phase III studies in the now-approved indications – two studies as adjunctive therapy to antidepressants in MDD and two studies in schizophrenia. As adjunctive therapy for MDD, the efficacy of Rexulti was evaluated in two, 6-week, placebo-controlled clinical trials of adult patients. Patients met the DSM-IV-TR criteria for MDD, with or without symptoms of anxiety, and previously failed to reach an adequate response during one to three treatment attempts with antidepressant therapy (ADT), and further failed to reach adequate response in a single-blind ADT phase for 8 weeks.

The efficacy of Rexulti was established in two, 6-week, phase III randomized, placebo-controlled clinical trials with fixed doses of Rexulti vs. placebo. Clinical trial data showed: Rexulti, at an adequate dose for 6 weeks, demonstrated statistically significant efficacy for the primary endpoint of PANSS (Positive and Negative Syndrome Scale). In one trial, change from baseline in PANSS total score for Rexulti at both 2 mg/day and 4 mg/day (-20.73 and -19.65) was superior to placebo (-12.01); in a second trial, the change from baseline in PANSS total score at a dose of 4 mg/day (-20.00 vs. -13.53, respectively) was superior to placebo (2 mg was not superior to placebo in this trial). The most common adverse reactions (incidence of 4% or greater, and twice the incidence of placebo) from the pooled safety data associated with Rexulti at 1, 2 and 4 mg vs. placebo, included weight gain (4% vs. 2%, respectively).