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Schizophrenia: FDA Approves New Injectable Drug To Treat Schizophrenia

First Posted: Oct 20, 2015 11:31 AM EDT
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The U.S. Food and Drug Administration recently approved a new injectable drug to treat schizophrenia, according to a news release.

Aristada (aripiprazole lauroxil) extended release injections were approved to treat adults with schizophrenia, when the drug is administered by a healthcare professional every four to six weeks, using an injection in the arm or buttocks.

"Long-acting medications to treat schizophrenia can improve the lives of patients," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "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 effectiveness of Aristada was demonstrated in a 12-week clinical trial with 622 participants.

The participants with severe schizophrenia, who had been stabilized with oral aripiprazole, saw that Aristada had maintained the treatment effect, according to the news release.

Aristada and other types of antipsychotic drugs that are used to treat schizophrenia have a box warning alerting healthcare professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis.

No drug in this class has been approved to treat patients with dementia-related psychosis. Aristada must be dispensed with a patient medication guide that describes important information about the drug's uses and risks, the FDA reported.

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

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