ARISTADA offers proven efficacy by reducing symptoms of schizophrenia
ARISTADA® (aripiprazole lauroxil) significantly improved Positive and Negative Syndrome Scale (PANSS) total scores at day 85 vs placebo.1,2
- In an exploratory analysis,* both ARISTADA arms reduced PANSS total score vs placebo at every visit from day 8 through day 852
- In exploratory analyses,* both arms showed improvement in mean positive, negative, and general PANSS subscales from baseline to day 85 vs placebo3
*Exploratory analyses: Analysis of all exploratory endpoints was supportive of the prespecified key primary and secondary endpoints. However, these analyses do not allow definitive efficacy conclusions regarding treatment effects of ARISTADA to be drawn.
- Based on a post hoc analysis† of the 12-week phase 3 trial, a subgroup of patients with PANSS total score >92 at baseline showed a mean reduction in PANSS total score from baseline to day 854
- Those receiving placebo (n = 99), ARISTADA 441 mg monthly (n = 95), and ARISTADA 882 mg monthly (n = 100) experienced a mean decrease in PANSS total scores of 7.44, 22.14, and 24.05, respectively4
†Post hoc analysis: The 12-week phase 3 study was not designed to prospectively assess, nor was it adequately powered to examine, the efficacy of ARISTADA in the treatment of this subgroup of patients. Therefore, there are limitations to these data, and no conclusions can be drawn from this post hoc analysis.
Efficacy of additional doses1
- The efficacy of ARISTADA 662 mg every month, 882 mg every 6 weeks, and 1064 mg every 2 months in the treatment of adults with schizophrenia was established by pharmacokinetic bridging studies
- These dosing regimens resulted in plasma aripiprazole concentrations that are within the range provided by doses of 441 mg monthly and 882 mg monthly
References: 1. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2018. 2. Meltzer HY, Risinger R, Nasrallah HA, et al. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015;76(8):1085-1090. 3. Citrome L, Risinger R, Cutler AJ, et al. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale—supportive analyses from a phase 3 study [published online ahead of print June 19, 2017]. CNS Spectr. doi:10.1017/S1092852917000396. 4. Potkin SG, Risinger R, Du Y, et al. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017;190:115-120.