The Food and Drug Administration has approved aripiprazole lauroxil, a long-acting injectable atypical antipsychotic, for the treatment of adults with schizophrenia.
Approval of the drug, which came Oct. 5, was based on results of a 12-week multicenter, randomized, controlled trial of 622 patients aged 18-70 years, with acute exacerbation of schizophrenia who had been stabilized with oral aripiprazole (J Clin Psychiatry. 2015;76[8]:1085-90).
Patients who received 441-mg or 882-mg injections of aripiprazole lauroxil every 4 weeks experienced significant reductions in Positive and Negative Syndrome Scale total scores from baseline to day 85, compared with those on placebo. The secondary efficacy outcome was improvement in the Clinical Global Impressions-Improvementscore at day 85. Insomnia, akathisia, headache, and anxiety were the most common adverse side effects.
Aripiprazole lauroxil, which will be marketed as Aristada, should be administered every 4-6 weeks. The drug joins two other long-acting injectables for treating schizophrenia – olanzapine (Zyprexa Relprevv) and aripiprazole (Abilify Maintena).
“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,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Like other atypical antipsychotics, Aristada will have a boxed warning about the increased risk of death associated with the off-label use of these drugs for treating older patients with psychosis tied to dementia. Aristada is manufactured by Alkermes.