FDA Approves Aristada to Treat Adults Suffering from Schizophrenia

FDA Approves Aristada to Treat Adults Suffering from Schizophrenia
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October 13, 2015

A new treatment option will soon be available to patients battling schizophrenia.

Last week, the Food and Drug Administration (FDA) issued an approval for Aristada (aripiprazole lauroxil) extended release injection for use in adults suffering from the mental disorder. The drug is intended to be administered by a health care professional every four to six weeks.

"Long-acting medications to treat schizophrenia can improve the lives of patients," Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient's needs."

The efficacy of Aristada was demonstrated by a 12-week clinical trial with 622 participants. In individuals with acute schizophrenia who had been stabilized with oral aripiprazole, Aristada was found to maintain the treatment effect more effectively than a placebo.

The most common side effect reported by participants receiving Aristada in clinical trials was feeling the urge to move constantly (akathisia).

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 years of age and include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.

Aristada is manufactured by Alkermes, Inc.