FDA Approves Drug for Schizophrenia and Major Depressive Disorder

The US Food and Drug Administration (FDA) announced the approval of Rexulti (brexpiprazole) as a treatment option for adults with schizophrenia or major depressive disorder (MDD).

The US Food and Drug Administration (FDA) announced the approval of Rexulti (brexpiprazole) as a treatment option for adults with schizophrenia or major depressive disorder (MDD).

There are 2.4 million adults living with schizophrenia and 15 million with MDD in the US. Rexulti, developed by Otsuka Pharmaceutical Co., Ltd. in partnership with H. Lundbeck A/S, proved to be superior against a placebo for both conditions.

“For some patients with MDD, antidepressant monotherapy is not enough, and these patients continue to suffer from unresolved symptoms,” one of the investigators Michael E. Thase, MD, professor of psychiatry and director of Mood and Anxiety Program at the University Pennsylvania School of Medicine, said in a news release.

In phase II and III clinical trials consisting of 4,300 participants with MDD, 2 mg and 3 mg of Rexulti in combination with antidepressant therapy (ADT) lowered scores on the MADRS (Montgomery-Asberg Depression Rating Scale). The average baseline MADRS score was 27 and the team tracked the outcomes over the course of 6 weeks in both studies.

The 2 mg treatment decreased the score by 8.36 and the 3 mg by 8.29. The placebo in combination with ADT demonstrated a reduction of only 5.15 and 6.33 in the same studies. It was noted that 1 mg of Rexulti was no better than the placebo.

“In the clinical trials that led to the FDA’s approval, adding brexpiprazole to ongoing antidepressant therapy helped MDD patients improve unresolved symptoms of MDD,” Thase confirmed.

Two phase III clinical trials were conducted to analyze the efficiency of the drug for patients with schizophrenia as well. The results showed statistical significance on the PANSS (Positive and Negative Syndrome Scale). A single adverse event, weight gain, was observed in at least 4% of patients.

Rexulti is expected hit the US market in early August 2015. The once daily oral drug is indicated as a treatment for schizophrenia and for an adjunctive therapy with ADT for MDD.