Lurasidone Evaluated for Relapse Risk in Schizophrenia Trial
Sunovion and Takeda announced results from a new study evaluating the efficacy and safety of lurasidone (Latuda; Sunovion) in the maintenance treatment of adults with schizophrenia. Lurasidone is a once-daily oral atypical antipsychotic currently indicated for the treatment of schizophrenia and major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate.
In the double-blind, placebo-controlled, randomized withdrawal study, adult patients with schizophrenia who were stabilized on lurasidone (40–80mg/day, flexibly dosed) during open-label treatment were randomized to either continued treatment with lurasidone 40mg/day or 80mg/day (flexibly dosed) or placebo for up to 28 weeks. The primary endpoint was time to relapse over 28 weeks of the double-blind phase.
Study results showed that patients who received lurasidone (N=144) experienced a significant delay in time to relapse compared to patients who received placebo (N=141) (P=0.039). Also, treatment with lurasidone was associated with a 33.7% reduction in risk of relapse vs. placebo (hazard ratio 0.663, 95% CI [0.447, 0.983]; P=0.041).
These results will be submitted to relevant health authorities for review and potential inclusion in the respective prescribing information.
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