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ARISTADA Pivotal Trial Design (N = 623)1

KEY INCLUSION CRITERIA

  • Experiencing acute exacerbation or relapse
  • Ages 18 to 70 years
  • PANSS total score of 70 to 120
  • Score ≥4 for at least 2 of the selected Positive Scale items
  • Clinical Global Impression-Severity of Illness (CGI-S) score ≥4

STUDY ENDPOINTS

  • Change in PANSS total score from baseline to day 85 (primary)
  • CGI-I score at day 85 (secondary)

ARISTADA® (aripiprazole lauroxil) was studied in a multicenter, randomized, double-blind, placebo-controlled trial in adult patients with schizophrenia (DSM-IV criteria).1,2

Abbreviation: IM, intramuscular.

Vertical dotted line indicates end of oral supplementation.

In a phase 3 study, ARISTADA was shown to reduce schizophrenia symptoms1,2

2X Greater mean reduction in panss total score vs placebo at day 85 (primary endpoint)1,2

  • Patients enrolled in the 12-week clinical trial were considered markedly ill, with mean baseline Positive and Negative Syndrome Scale (PANSS) total scores of 93.9 (placebo), 92.6 (ARISTADA 441 mg monthly), and 92.0 (ARISTADA 882 mg monthly)2,3

Twice as many patients receiving ARISTADA had CGI-I scores that were very much improved or much improved at day 85 vs placebo (secondary endpoint)4

CGI-I SCORE AT DAY 85 (SECONDARY ENDPOINT)4

  • The Clinical Global Impression-Improvement (CGI-I) scale allows the clinician to assess and rate improvement in mental illness on a scale of 1 (very much improved) to 7 (very much worse) based on the change in clinical condition from baseline2
  • In an exploratory analysis,* improvement in CGI-I was seen for both ARISTADA groups vs the placebo group at each post-baseline visit4

*Exploratory analysis: 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.

  • In a post hoc analysis of the 12-week phase 3 clinical trial, improvement was seen in a subgroup of patients with more severe symptoms. Patients with PANSS total score >92 at baseline showed a mean reduction in PANSS total score from baseline to day 85. 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, respectively.5

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 THE 2-MONTH DOSE

The efficacy of ARISTADA 441 mg monthly and 882 mg monthly was established in the phase 3 clinical trial. The efficacy of ARISTADA 662 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months was established by pharmacokinetic bridging, which demonstrated that these dosing regimens resulted in plasma aripiprazole concentrations that are within the range provided by doses of 441 mg monthly and 882 mg monthly.2

“It’s reassuring to know that I have 2 months until my next dose.”

- Nora

Learn about long-term data for ARISTADA

See Extension Study Data
References: 1. 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. 2. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2018. 3. Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR. What does the PANSS mean? Schizophr Res. 2005;79(2-3):231-238. 4. Data on file. Alkermes, Inc. 5. 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.