FDA Clears Long-Lasting Drug for Schizophrenia

Oct. 6, 2015 -- The FDA has approved a version of the antipsychotic drug aripiprazole that adults with schizophrenia can take every 4-6 weeks.

Aristada (aripiprazole lauroxil) comes in a shot that a doctor gives you in the arm or buttocks. The drug's maker said it expects to launch the drug "immediately."

Doctors call it a "long-acting" drug because it stays in your system and is effective over a longer period of time.

"Long-acting medications to treat schizophrenia can improve the lives of patients," says Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a news release. "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 drug’s approval was based on data from a study of more than 600 people with the brain disorder.

People in the study generally tolerated aripiprazole lauroxil well. The most common side effects were insomnia, akathisia (agitation and restlessness), and headaches.

Aripiprazole lauroxil and similar drugs carry a boxed warning alerting doctors about an increased risk for death if the drugs are used to treat behavioral problems in older patients with dementia-related psychosis - a purpose they aren’t approved for. "No drug in this class is approved to treat patients with dementia-related psychosis," the FDA says.

"Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering. New treatment options are needed to help patients and their families better manage this illness," says David Henderson, MD, associate professor of psychiatry at Massachusetts General Hospital, in a news release from Alkermes, the drug’s manufacturer.