FDA Approves New Dosing Duration for Aristada
The US Food and Drug Administration recently approved a new 2-month dose for Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of patients with schizophrenia.
Aristada is an injectable atypical antipsychotic that should be administered by a health care professional, and is now available in 4 doses with 3 dosing duration options: 441 mg, 662 mg, or 882 mg once a month, 882 mg once every 6 weeks, and 1064 mg once every 2 months. The newly approved dose provides patients with the option to treat their symptoms with 6 injections per year, reducing the burden of taking oral antipsychotic medicine and giving patients and health care providers more flexibility.
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The most common adverse event associated with Aristada was akathisia. Patients were also at an increased risk for developing neuroleptic malignant syndrome, tardive dyskinesia, pathological gambling or other compulsive behaviors, orthostatic hypotension, as well as experiencing metabolic changes including hyperglycemic, dyslipidemia, and weight gain.
In addition, hypersensitive reactions can occur and range from pruritus or urticarial to anaphylaxis. Stroke, transient ischemic attacks and falls have been reported in elderly patients with dementia-related psychosis who were treated with apriprazole.
FDA approves two-month Aristada for treatment of schizophrenia [press release]. Dublin, Ireland: Alkermes, June 6, 2017. http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=RssLanding&cat=news&id=2279079. Accessed June 6, 2017.