The U.S. Food and Drug Administration announced the approval of Rexulti (brexpiprazole) as treatment for schizophrenia and an add-on for antidepressant medication aimed at addressing major depressive disorder.

As a chronic brain disorder, schizophrenia is severe and debilitating, affecting a percent of the American population. Symptoms typically manifest in adults below 30 years old and may include being withdrawn or suspicious, believing others are reading their thoughts or controlling their minds and hearing voices.

Major depressive disorder, on the other hand, is severe as well, a disabling brain disorder that is characterized by changes in mood and other symptoms that get in the way of an individual's ability to eat, sleep, study, work and generally enjoy activities considered to be pleasurable. Episodes recur often but it is also possible for a depressive experience to occur just once.

Other major depressive disorder symptoms include dramatic change in appetite or weight, loss of interest in once-enjoyable activities, excessive sleeping or insomnia, pacing or restlessness, feelings of worthlessness or guilt, increased fatigue, impaired concentration, and thoughts of suicide or suicide attempts. However, not all of these symptoms are experienced by everyone diagnosed with major depressive disorder.

"Medication affect everyone differently so it is important to have a variety of treatment options available for patients with mental illness," said Mitchell Mathis, M.D. Division of Psychiatry Products director from the Center for Drug Evaluation and Research of the FDA.

To determine Rexulti's effectiveness as a schizophrenia treatment, two clinical trials were carried out for six weeks, assessing response in 1,310 subjects, some of which were assigned to take placebo.

Two clinical trials were also conducted to see how effective Rexulti will be as an add-on treatment for major depressive disorder compared to just antidepressant and antidepressant and placebo. There were 1,046 subjects for these studies, in which those taking Rexulti reported experiencing fewer symptoms than those given placebo.

The most common of the side effects shown during the studies were an inner sense of restlessness, like a constant need to move, and weight gain in those taking Rexulti.

Rexulti and other medications designed for treating schizophrenia come with warnings alerting healthcare providers about the increased risks of death that are associated with the drugs' off-label use as treatment for psychosis in older people diagnosed with dementia.

Made by Otsuka Pharmaceutical Company Ltd., Rexulti must be prescribed to a patient with a medication guide enclosed to describe important information regarding the risks and uses of the drug.

Photo: Yuliya Libkina | Flickr

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