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Psych Congress  

Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia: A Post-hoc Analysis

Authors  
Joseph P McEvoy, MD; Yangchun Du, PhD; Arielle D Stanford, MD; Peter J Weiden, MD
Sponsor  
Alkermes, Inc.

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Background: Aripiprazole lauroxil (AL) is an extended-release injectable antipsychotic approved for treatment of schizophrenia. This post-hoc analysis evaluated the durability of the therapeutic effect of long-term treatment with AL in patients with schizophrenia following successful treatment of an acute psychotic episode.

Methods: This was a post-hoc analysis in a subgroup of patients (N=181) who entered a 52-week, open-label extension study after being successfully stabilized with one of two doses of AL (441 or 882 mg) in a pivotal phase 3, 12-week, placebo-controlled, randomized clinical trial; all patients continued to receive the same dose as previously assigned. Durability of therapeutic effect was measured by the proportion of patients completing the 52-week course of AL, evaluating trajectories of Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scale scores beyond the first 12 weeks.

Results: In total, 181 patients treated with AL entered the extension study; 73% and 66% of patients from the 441 mg and 882 mg groups, respectively, received all 13 AL injections scheduled every 4 weeks over 52 weeks. Both groups continued on a positive trajectory of symptom improvements (P<0.05 for reductions in PANSS total, PANSS positive and negative symptom subscales, and CGI-S scale scores) from Week 12 to end of follow-up.

Conclusions: These post-hoc analyses of a subgroup of patients demonstrate the continued therapeutic efficacy of AL after successful treatment of an acute episode of schizophrenia. Both AL 441 mg and 882 mg groups had similar retention rates and degree of symptom improvement.

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