FDA approves Rexulti for schizophrenia, major depressive disorder in adults

Affecting about 1 percent of Americans, the disorder is characterized by hearing voices, believing other people are reading your mind, withdrawal and suspicion.

Rexulti was also tested as an add-on therapy for major depression. Episodes of depression often recur throughout a person’s lifetime, although some may experience a single occurrence. Other symptoms may include loss of interest in daily life, weight change, insomnia, restlessness, fatigue, feeling guilty or worthless, and inability to concentrate. Not all people with MDD experience the same symptoms. “Medications affect everyone differently so it is important to have a variety of treatment options available for patients with mental illnesses”.

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. He goes on to say, “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”.

Study participants who received brexpiprazole reported fewer symptoms of depression than those who received placebo.

Like other schizophrenia drugs, Rexulti has a boxed warning about an increased risk of death associated with unapproved use of the drugs to treat behavioral problems in people with dementia-related psychosis.

No drug in this class is approved to treat dementia-related psychosis, according to the FDA.

Brexpiprazole has a boxed warning about an increased risk for suicidal thinking and behavior among children, adolescents and young adults taking antidepressants.

Finally, the FDA says, “Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors”.

The agency based its decision on seven clinical trials, three of which examined the drug’s effect on schizophrenia and four testing it as an adjunctive therapy for MDD.

The approval comes at a good time for Otsuka, a unit of Otsuka Holdings Co Ltd. The company’s USA patent for a similar anti-psychotic, Abilify, which is sold by Bristol-Myers Squibb Co in the United States, expired in April.