In a phase 3 study, ARISTADA was shown to reduce schizophrenia symptoms1,2
- 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
- The Clinical Global Impression-Improvement (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 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