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Psych Congress  

Efficacy of Lurasidone in the Treatment of Agitation Associated With Acute Schizophrenia

Authors  
Peter Werner, PhD, Michael Allen, MD. Andrei Pikalov, MD, PhD. Fengbin Jin, PhD. Josephine Cucchiaro, PhD. Antony Loebel, MD.
Sponsor  
Sunovion Pharmaceuticals Inc.

Objectives: To evaluate the efficacy of lurasidone in reducing agitation in patients hospitalized for acute exacerbation of schizophrenia.
Methods: This analysis was performed on pooled data from five 6-week, double-blind, placebo-controlled studies in patients with schizophrenia who were randomized to fixed 40-160 mg once-daily doses of lurasidone. Efficacy assessments were PANSS total score and the PANSS Excited Component (PEC) subscore recorded on day 3/4 and day 7 in patients (n=773) experiencing clinically relevant levels of agitation (high agitation defined as a PEC score ≥14 at baseline). 
Results: In the high agitation group, treatment with lurasidone was associated with a significantly lower attrition rate compared with placebo (36.0% vs. 48.1%; p<0.01). Treatment with lurasidone vs. placebo was associated with significantly greater improvement in PANSS-EC scores at days 3/4 (-1.6 vs. -1.0; p<0.001), day 7 (-2.3 vs. -1.6; p<0.001), and at week 6 endpoint (-5.5 vs. -3.8; p<0.001). Treatment with lurasidone was also associated with significantly greater improvement in PANSS total scores at days 3/4 (-5.1 vs. -4.0; p<0.001), day 7 (-9.0 vs. -6.5; p<0.001), and at week 6 endpoint (-27.2 vs. -18.4; p<0.001). Higher endpoint responder rates (≥20% improvement in PANSS total) with lurasidone vs. placebo were observed in the high agitation group (64.3% vs. 43.4%; p<0.01).
Conclusions: Treatment with lurasidone significantly reduced agitation as early as day 3, with improvement maintained through week 6. Lurasidone also significantly improved both the PANSS total and CGI-S scores from day 7 onward in patients with high baseline agitation.

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