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52-WEEK SAFETY STUDY

Exploring safety and therapeutic effect of ARISTADA in continuing and de novo patients1

STUDY DESIGN1

  • This was a 52-week open-label safety study of 2 fixed doses of ARISTADA® (aripiprazole lauroxil) 441 mg or 882 mg administered by intramuscular injection every 4 weeks
  • The study enrolled 236 patients who completed the 12-week phase 3 study, as well as 242 new adults with chronic stable schizophrenia, all of which were administered 882 mg of ARISTADA by intramuscular injection every 4 weeks
  • 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

  • The primary objective was to assess the long-term safety and tolerability of ARISTADA in patients with stable schizophrenia

ADVERSE EVENTS (AEs) OCCURRING IN ≥2% OF PATIENTS DURING THE 52-WEEK SAFETY STUDY1

aMajority reported in de novo patients (16 patients).

  • Adverse events leading to discontinuation were reported in 5.9% (n = 28) of the total population (N = 478)1
  • Adverse events were generally consistent with what is established and known of the safety of aripiprazole1
  • No new safety events were observed during this 52-week safety study1

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

- Andy

The durability of effect of ARISTADA was observed over the 52-week safety study period (secondary outcome)1

  • The results of the study demonstrate the safety and tolerability of the long-term treatment with aripiprazole lauroxil in patients with schizophrenia1

Long-term efficacy was further evaluated in a post hoc analysis2

  • A post hoc analysis assessed long-term outcomes for a subgroup of patients (N = 174) who entered a 52-week safety study after being successfully stabilized during a pivotal 12-week, placebo-controlled, randomized clinical trial and had at least 1 Positive and Negative Syndrome Scale (PANSS) assessment after drug administration in the safety study*
  • Patients received 1 of 2 doses of ARISTADA (441 mg or 882 mg) administered by intramuscular injection every 4 weeks during both the 12-week study and the 52-week safety study
  • The objective was to evaluate the durability of the therapeutic effect of long-term treatment with ARISTADA in patients with schizophrenia following successful treatment of an acute psychotic episode
  • 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)*

MEAN CHANGE FROM BASELINE IN PANSS TOTAL SCORE IN THE ACTIVE ROLLOVER PATIENT SUBGROUP2,a

aIn patients who had at least 1 PANSS assessment after drug administration in the 52-week safety 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 safety 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. Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2018:1-9. 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.