Latuda Efficacy, Safety Assessed in Long-Term Bipolar Disorder Study
Sunovion announced positive results from an extension study evaluating the long-term safety, tolerability and efficacy of Latuda (lurasidone HCI) as monotherapy or as an adjunct to lithium or valproate in adults with major depressive episodes associated with bipolar I disorder. Study findings were published in the journal Depression and Anxiety.
The study is a six-month, open-label extension of three, six-week, double-blind, placebo-controlled trials evaluating Latuda vs. placebo in patients with bipolar depression. The primary objective of the extension study was to evaluate the safety and tolerability of Latuda as monotherapy or adjunctive therapy. Secondary objective included the evaluation of the effectiveness of Latuda in maintaining improvement in depressive symptoms.
Results from the extension study demonstrated that once-daily treatment with flexible doses of Latuda (20–120mg/day) for 6 months following a six-week, placebo-controlled treatment period was well-tolerated with minimal changes in weight and metabolic parameters. Of the 813 patients (38.9% monotherapy; 61.1% adjunctive) who were treated with Latuda, 559 completed the study. The discontinuation rate due to an adverse event for the monotherapy group was 6.9% and 9% in the adjunctive group. Changes from double-blind baseline to month six for the monotherapy and adjunctive therapy groups, respectively, were as follows:
— Mean changes in weight: +0.85 and +0.88kg
— Median changes in total cholesterol: 0.0 and +2.0 mg/dL
— Median changes in triglycerides: +5.0 and +5.0 mg/dL
— Median changes in glucose: –1.0 and 0.0 mg/dL
In addition, the study also showed that 6-month treatment with Latuda was associated with sustained improvement in depressive symptoms based on observed case data over time and assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).
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