Two-Month Dosing Option Approved for Aristada in Schizophrenia

The new dosing option allows patients with schizophrenia to treat their symptoms with just 6 injections per year

Alkermes announced that the Food and Drug Administration (FDA) has approved a 2-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. This allows patients with schizophrenia to now treat their symptoms with just 6 injections per year.

Aristada is approved in 4 doses as the following 3 dosing options that can be started at any dose or interval:

  • 441mg, 662mg, or 882mg once monthly 
  • 882mg once every 6 weeks
  • 1064mg once every 2 months

Aristada, an atypical antipsychotic, is a prodrug of aripiprazole. Once injected intramuscularly, aripiprazole lauroxil is converted to aripiprazole. The mechanism of action in schizophrenia is thought to be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.

Aristada is available as a kit containing the prefilled syringe and safety needles. The new 2-month dose is expected to launch mid-June. 

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