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PIVOTAL TRIAL

Pivotal trial: A 12-week, phase 3, randomized, double-blind, placebo-controlled, fixed-dose study evaluating the efficacy and safety of ARISTADA in adults with schizophrenia1,2

ARISTADA Pivotal Trial Design (N = 622)1,2

KEY INCLUSION CRITERIA1,2

  • 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
  • CGI-S score ≥4

STUDY ENDPOINTS1,2

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

Abbreviations: CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity of Illness; IM, intramuscular; PANSS, Positive and Negative Syndrome Scale.

Vertical dotted line indicates end of oral supplementation.

ARISTADA was shown to reduce PANSS total scores in markedly ill patients1,3

Patients enrolled in the 12-week clinical trial were considered markedly ill, with mean baseline PANSS total scores of 93.9 (placebo), 92.6 (ARISTADA 441 mg monthly), and 92.0 (ARISTADA 882 mg monthly).1,3

MEAN BASELINE PANSS TOTAL SCORES1

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

ARISTADA patients experienced an improvement in clinical condition2,4

  • The CGI-I scale allows the clinician to assess and rate improvement in schizophrenia on a scale of 1 (very much improved) to 7 (very much worse) based on the changes in clinical condition from baseline1

CGI-I SCORE AT DAY 85 (SECONDARY ENDPOINT)2,4

  • 2 times as many patients receiving ARISTADA® (aripiprazole lauroxil) had CGI-I scores that were very much improved or much improved at day 85 vs placebo (secondary endpoint)4

ARISTADA has been evaluated for safety in 1180 adult patients in clinical trials in schizophrenia1

ADVERSE REACTIONS IN ≥2% OF ARISTADA-TREATED PATIENTS AND THAT OCCURRED AT GREATER INCIDENCE THAN IN PLACEBO-TREATED PATIENTS IN THE 12-WEEK CLINICAL TRIAL1

  • In an open-label pharmacokinetic study, adverse reactions associated with the use of ARISTADA were similar across the 441 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months dose groups1

DISCONTINUATIONS

  • In the 12-week clinical trial, discontinuations due to adverse events in patients receiving ARISTADA were lower than for placebo: 6.8% for the 441 mg dose, 2.9% for the 882 mg dose, and 17.9% for placebo2
  • In the placebo group, adverse events leading to discontinuation were related to exacerbation of psychosis/schizophrenia. Otherwise, adverse events leading to discontinuation were similar between the 3 treatment groups4

Prolactin levels at baseline and last post-baseline visit5

aMean baseline prolactin: placebo: 10.1 (men), 28.8 (women); ARISTADA 441 mg monthly: 10.3 (men), 27.1 (women); ARISTADA 882 mg monthly: 10.2 (men), 25.7 (women). Normal prolactin: 4.0 to 15.2 ng/mL (men), 4.8 to 23.3 ng/mL (women).5

  • In the 12-week clinical trial, mean prolactin levels decreased below baseline measurements starting at day 29 through day 85 in both ARISTADA groups compared with placebo5
  • Baseline prolactin levels may have been affected by previous antipsychotic medication use prior to starting the study4
  • Patients in the clinical trial had previously established tolerability to aripiprazole, which may affect prolactin measurements2

MEAN increase in body weight from baseline to last post-baseline assessment5

  • In the 12-week clinical trial, mean increase in body weight from baseline to last post-baseline assessment was 0.02 pounds for placebo (n = 207), 1.6 pounds for ARISTADA 441 mg monthly (n = 207), and 1.9 pounds for ARISTADA 882 mg monthly (n = 208)5
  • The percentage of patients with ≥7% increase in weight noted at the last post-baseline visit during the treatment period was 6% for placebo, 10% for ARISTADA 441 mg monthly, and 9% for ARISTADA 882 mg monthly1

Akathisia onset relative to injection number and study day4

  • Akathisia was the most common adverse reaction (incidence ≥5% and at least twice the rate of placebo in patients treated with ARISTADA in the 12-week clinical trial)1
  • 2 out of 415 patients discontinued ARISTADA due to akathisia, which was not dose-related4
  • Benzodiazepines and short-acting beta-blockers were permitted for treatment-emergent akathisia as needed4

INJECTION-SITE PAIN

  • In the phase 3 clinical trial, overall injection-site reactions were reported in 2% (placebo), 4% (441 mg monthly), and 5% (882 mg monthly) of patients1
    • Of these, the incidence of pain with the first injection was 2%, 3%, and 4%, respectively, and ≤1% with each subsequent injection. Other injection-site reactions (induration, swelling, and redness) were <1%1

Learn about the 52-week safety study

SEE THE STUDY
References: 1. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2019. 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. 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. Nasrallah HA, Newcomer JW, Risinger R, et al. Effect of aripiprazole lauroxil on metabolic and endocrine profiles and related safety considerations among patients with acute schizophrenia. J Clin Psychiatry. 2016;77(11):1519-1525.