Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has approved Rexulti (brexpiprazole) tablets as adjunctive therapy for the treatment of adults with major depressive disorder (MDD), and as treatment for adults with schizophrenia.

Rexulti, an atypical antipsychotic, is presumed to work through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Rexulti also shows high affinity for these receptors and for noradrenaline alpha1B/2C receptors.

Rexulti was studied in two six-week, placebo-controlled clinical trials of adults with MDD. The primary endpoint for both studies was change in Montgomery-Åsberg Depression Rating Scale (MADRS). Study data showed that Rexulti plus antidepressant therapy (ADT) at 2mg and 3mg was superior to placebo. A decrease in baseline MADRS of 8.36 (2mg) and 8.29 (3mg) was seen vs. placebo + ADT decreases of 5.15 and 6.33 in the respective studies.

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Rexulti was also studied in two six-week, Phase 3 randomized, placebo-controlled trials in adults with schizophrenia comparing fixed doses of Rexulti vs. placebo. Study data showed treatment with Rexulti for 6 weeks showed statistically significant efficacy for the primary endpoint of Positive and Negative Syndrome Scale (PANSS). In one trial, the change from baseline in PANSS total score in the Rexulti group was -20.73 (2mg) and -19.65 (4mg) vs. -12.01 in the placebo group. In the second trial, the change from baseline in PANSS total score was -20.00 in the Rexulti 4mg group vs. -13.53 in the placebo group; the 2mg dose was not superior to placebo in this trial.

Rexulti will be available in 0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg strength tablets in 30-count bottles. It is expected to launch in early August 2015.

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