FDA Issues New Approval for Drug to Treat Schizophrenia

FDA Issues New Approval for Drug to Treat Schizophrenia
July 14, 2015

A medication already used to treat depression has been given federal approval to be used as a treatment for adults with schizophrenia.

On July 10, the U.S. Food and Drug Administration (FDA) approved Rexulti (brexpiprazole) to treat adults with the disorder. The drug, manufactured by Tokyo-based Otsuka Pharmaceutical Company, already had an approval to treat major depressive disorder (MDD), commonly referred to as depression.

Schizophrenia is a chronic, severe, and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 and include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.

"Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities," Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "Medications affect everyone differently so it is important to have a variety of treatment options available for patients with mental illnesses."

The effectiveness of Rexulti in treating schizophrenia was evaluated in 1,310 participants in two six-week clinical trials. Rexulti was shown to reduce the occurrence of symptoms of schizophrenia compared to placebo.

The most common side effects reported by participants taking Rexulti in clinical trials included weight gain and an inner sense of restlessness, such as feeling the need to move.

According to FiercePharma, the new approval comes at a great time for Otsuka. One of Otsuka's other products, the antipsychotic Abilify, has recently been challenged by generic competition, threatening profits for the pharmaceutical giant.