FDA Approves Novel Therapy for Schizophrenia, Depression

The FDA has approved Otsuka and Lundbeck’s brexpiprazole (Rexulti) as a once-daily adjunctive therapy for adults with major depressive disorder (MDD), as well as for the treatment of schizophrenia in adults.

The efficacy of Rexulti as adjunctive therapy for MDD was established in 2 placebo-controlled clinical trials of adult patients who had previously failed to achieve an adequate response during 1 to 3 treatment attempts with antidepressant therapy (ADT). The research team deemed 2 mg or 3 mg of Rexulti superior to placebo in reducing MDD symptoms, though the 1-mg dose was not found to be superior.

“For some patients with MDD, antidepressant monotherapy is not enough, and these patients continue to suffer from unresolved symptoms,” said study investigator Michael E. Thase, MD, in a press release. “In the clinical trials that led to the FDA’s approval, adding brexpiprazole to ongoing ADT helped MDD patients improve unresolved symptoms of MDD.”

Rexulti’s efficacy in treating schizophrenia was also demonstrated in 2 placebo-controlled clinical trials, during which the 4-mg dose of the drug was deemed superior to placebo in reducing symptoms.

“Psychiatric diseases remain a challenging therapeutic area where many people are unsatisfied with their treatments,” stated Otsuka president Tatsuo Higuchi. “Today’s approval of Rexulti is another example of Otsuka and Lundbeck’s commitment to bringing new therapeutic alternatives to the mental health community.”

The most common adverse events reported by trial patients in the MDD studies included akathisia and weight increase. In the schizophrenia trials, the drug was associated with an increased risk of weight increase and somnolence.

“All treatment options require health care providers, patients, and caregivers to balance efficacy and tolerability in managing their diseases,” said Lundbeck president and CEO Kåre Schultz. “We are proud to introduce Rexulti to help adult patients living with MDD and schizophrenia.”

Otsuka and Lundbeck plan to launch Rexulti in early August 2015, according to a manufacturer press release.