FDA Approves Aristada For Schizophrenia Treatment

By Paul Gaita 10/09/15

Can Aristada be the first step in helping the 20 million people worldwide suffering from schizophrenia?

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In a press release issued on October 6, the U.S. Food and Drug Administration (FDA) announced its approval of Aristada (aripiprazole lauroxil) to treat adults with schizophrenia.

The drug is an extended-release injectable version of Abilify, a once-a-day oral treatment developed by Otsuka Pharmaceuticals and distributed by Bristol-Myers Squibb in the United States. Dublin-based pharma Alkernes manufactures Aristada, which is marketed as the first atypical antipsychotic with once-monthly and six-week dosing options in a range of strengths to meet individual patient needs.

The FDA approval of Aristada was based on a 12-week clinical trial with 622 participants. The results of the study showed that the drug was “generally well tolerated” by participants with acute schizophrenia, with the most commonly reported adverse side effects being insomnia, headache, and akathisia, which is described as a feeling of uncontrolled restlessness. The drug is also not approved for use with elderly patients with dementia-related psychosis, who are at a greater risk of death when treated with antipsychotic medication.

Aristada is just one of several long-acting injectable drugs available for treatment of schizophrenia, included Zyprexa. The National Institutes of Health, as well as many medical professionals, also recommend that psychosocial interventions are an effective treatment for the disorder, and should be used in conjunction with any medication, as those patients who do participate in such treatments are more likely to take their medication on a regular basis.

An estimated 2.4 million American adults and more than 20 million worldwide have been diagnosed as having schizophrenia, according to the World Health Organization.

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.