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EXTENSION STUDY

Exploring safety and therapeutic effect of ARISTADA in continuing and de novo patients over 52 weeks1

STUDY DESIGN1

  • Patients previously receiving monthly ARISTADA® (aripiprazole lauroxil) 441 mg (n = 81) or 882 mg (n = 100) in the 12-week phase 3 study continued their assigned dose
  • Placebo patients from the study switched to monthly ARISTADA at a dose of 441 mg (n = 29) or 882 mg (n = 26) based on the volume of their prior placebo injection
  • De novo patients with chronic stable schizophrenia (n = 242) received ARISTADA 882 mg every 4 weeks as they entered the study
  • Patients on prior placebo and de novo patients received active oral aripiprazole 21-day supplementation, whereas patients who had received prior active ARISTADA received placebo

STUDY OUTCOMES1

  • Long-term safety and tolerability of ARISTADA in patients with stable schizophrenia (primary)
  • The durability of the therapeutic effect of ARISTADA was also assessed (secondary)

ADVERSE EVENTS (AEs) OCCURRING IN ≥2% OF PATIENTS DURING THE 52-WEEK EXTENSION PERIOD1

aMajority reported in de novo patients (16 patients).

  • Adverse events leading to discontinuation were reported in 5.9% (n = 28) of the total population1
  • Adverse events were generally consistent with what is established and known of the safety of aripiprazole1

“The 2-month dose (1064 mg) works for me. I prefer getting ARISTADA every 2 months.”

- Andy

Continued therapeutic benefit of ARISTADA was observed over the 52-week extension period

  • Decreases in PANSS total score from baseline to week 64 were observed in both treatment groups: 441 mg monthly and 882 mg monthly2

Long-term efficacy was evaluated in a post hoc analysis

  • A post hoc analysis assessed long-term outcomes for a subgroup of patients who entered a 52-week extension study after being successfully stabilized with 1 of 2 doses of ARISTADA (441 mg or 882 mg monthly) in the 12-week study2,3*
  • Patients from the acute-phase study who continued in the 52-week study were observed to have sustained and gradual improvements in PANSS total score for both dose groups through week 64 (least squares mean [standard error] change from week 12 was -8.1 [1.3] and -7.2 [1.2] for the 441 mg and 882 mg cohorts, respectively)2*

MEAN CHANGE FROM BASELINE IN PANSS TOTAL SCORE IN ACTIVE ROLLOVER PATIENTS2,a

aIn patients who had at least 1 PANSS assessment after drug administration in the extension study.2

bIndicated weeks denote assessment time points.2

Abbreviation: SD, standard deviation.

*This post hoc analysis of active rollover patients from the 12-week acute-phase study was not designed to prospectively assess, nor was it powered to examine, the efficacy of ARISTADA in this subgroup of patients. No definitive conclusions of efficacy can be drawn from these results.

In addition to the inherent limitations of post hoc analyses, limitations of this analysis include the preferential selection of study participants and differing assessment intervals between the 12-week study and the 52-week extension study.2

See how to start your patients on ARISTADA® (aripiprazole lauroxil) with the ARISTADA INITIO™ (aripiprazole lauroxil) regimen

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References: 1. Data on file. Alkermes, Inc. 2. McEvoy JP, Risinger R, Mykhnyak S, et al. Durability of therapeutic response with long-term aripiprazole lauroxil treatment following successful resolution of an acute episode of schizophrenia. J Clin Psychiatry. 2017;78(8):1103-1109. 3. 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.