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FDA Approves Schizophrenia Treatment Aristada
Aripiprazole lauroxil (Artistada, Alkermes) is an extended-release injectable suspension approved for the treatment of schizophrenia. It is the first atypical antipsychotic with once-monthly and once-every-six-weeks dosing options.
FDA approval was partly based on data from a phase 3 study in which multiple dosing strengths of aripiprazole lauroxil met the primary endpoint with statistically significant and clinically meaningful reductions in positive and negative syndrome scale (PANSS) total scores at week 12and demonstrated significant improvements in schizophrenia symptoms compared with placebo. The most common adverse events were insomnia, akathisia, and headache. The study was published in the June 2015 issue of the Journal of Clinical Psychiatry.
According to Alkermes, the range of dose strengths and dosing-interval options with aripiprazole lauroxil are designed to address the individual needs of patients and the challenges in treatingschizophrenia. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period and help health care providers track patient adherence.
According to BloombergBusiness, the drug will cost approximately $1,500 a month. The cost for an individual patient would depend on the dose and would be comparable to already approved schizophrenia drugs, such as Johnson & Johnson’s Risperdal (risperidone) and Invega (paliperidone), Alkermes said.
Sources: Alkermes, October 5, 2015; and BloombergBusiness, October 5, 2015.