Alkermes announced that the Food and Drug Administration (FDA) has approved Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia, the first atypical antipsychotic with once-monthly and 6-week dosing options.
The long-acting injectable antipsychotic provides blood concentrations of the active ingredient that remains within a therapeutic range for an extended period of time and helps healthcare providers to track adherence. Aristada is a prodrug of aripiprazole that converts to aripiprazole once in the body via an intramuscular injection. Its efficacy could be mediated through a combination of partial agonist activity D2 and 5- HT1A receptors and antagonist activity at 5-HT2A receptors.
The approval of Aristada was based on data from a Phase 3 randomized, double-blind, placebo-controlled trial (n=623) in patients with schizophrenia. Study data showed that multiple 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. Also, the study met its key secondary endpoint and demonstrated significant improvements in schizophrenia symptoms vs. placebo. The most common side effect reported by participants receiving Aristada in clinical trials was akathisia. Additional study findings are published in The Journal of Clinical Psychiatry.