Sunovion has announced positive results from a study evaluating Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years old.
A double-blind, placebo-controlled six week study randomized 285 adolescents with schizophrenia to receive fixed doses of Latuda 40mg/day, 80mg/day or placebo. At week 6, the Latuda 40mg/day arm displayed an improvement in Positive and Negative Syndrome Scale (PANSS) of –8.0 (P<0.001, effect size=0.51) and an improvement in Clinical Global Impression-Severity (CGI-S) of –0.47 (P<0.001, effect size=0.49). The Latuda 80mg/day arm showed an improvement of –7.7 (P<0.001, effect size=0.48) in PANSS score and of –0.42 (P=0.002, effect size=0.45) in CGI-S score.
The data also showed minimal changes in weight and metabolic parameters:
- Weight: +0.17 kg for Latuda 40mg/day, +0.49 kg for Latuda 80mg/day and +0.05 kg for placebo
- Cholesterol: –4.0 mg/dL for Latuda 40mg/day, –2.0 mg/dL for Latuda 80mg/day and –7.0 mg/dL for placebo
- Triglycerides: –2.0 mg/dL for Latuda 40mg/day, +7.0 mg/dL for Latuda 80mg/day and –2.0 mg/dL for placebo
- Glucose: 0.0 mg/dL for Latuda 40mg/day, +1.0 mg/dL for Latuda 80mg/day and 0.0 mg/dL for placebo
- Prolactin: Males: +0.8 ng/mL for Latuda 40mg/day, +1.0 ng/mL for Latuda 80mg/day and 0.0 ng/mL for placebo; females: +0.6 ng/mL for Latuda 40mg/day, +4.4 ng/mL for Latuda 80mg/day and +0.7 ng/mL for placebo
The most common adverse event was somnolence (15.5%, in the 40mg/day group; 13.5%, 80mg/day; 7.1%, placebo), followed by nausea (12.7%, 40mg/day; 14.4%, 80mg/day; 2.7%, placebo) and vomiting (8.2%, 40mg/day; 6.7%, 80mg/day; 1.8%, placebo).
These results will support the supplemental New Drug Application (sNDA) for Latuda submitted to the Food and Drug Administration. Latuda is currently indicated to treat major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of schizophrenia in adults.
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