FDA approves Aristada (aripiprazole lauroxil) for schizophrenia- Alkermes

The FDA has approved Aristada (aripiprazole lauroxil), from Alkermes, an extended-release injectable suspension for the treatment of schizophrenia. Aristada is an antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication by injection.

The FDA approval was based on data from a randomised, double-blind, placebo-controlled, phase III study in 623 patients with schizophrenia. Data from that trial showed that multiple dose strengths of Aristada met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, met the key secondary endpoint and demonstrated significant improvements in schizophrenia symptoms versus placebo. The most common adverse events in the study were insomnia, akathisia (inability to keep still) and headache. The results of the study were published in June 2015 by The Journal of Clinical Psychiatry.

Comment: Otsuka and Lundbeck received FDA approval for their once-monthly Abilify Maintena in 2013, putting Alkermes well behind. Johnson & Johnson/Janssen also has two long-acting injectables, Risperdal Consta and Invega Sustenna, on the market.