Sunovion reports successful study of Latuda (lurasidone HCI) for treatment of schizophrenia in adolescents.

Sunovion Pharmaceuticals Inc. has announced the results of a study evaluating Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents ages 13 to 17 years. Patients taking fixed doses of Latuda 40 mg/day or 80 mg/day in the 6-week study showed statistically significant and clinically meaningful improvement in symptoms of schizophrenia compared to placebo treatment. Latuda was also generally well tolerated, with limited effects on weight and metabolic parameters. The study results were presented at a medical conference in New York, New York.

In the randomized, double-blind, placebo study, adolescent patients were randomized to receive fixed doses of Latuda 80 mg/day or placebo. The primary efficacy endpoint was change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6, and the key secondary endpoint was change from baseline in Clinical Global Impression-Severity (CGI-S) scale at Week 6, which assessed global severity of illness. Latuda was associated with a statistically significant reduction in PANSS total scores and CGI-S scores at Week 6 compared to placebo for both dose groups, with a placebo-adjusted, least-squares (LS) mean improvement as follows: Latuda 40 mg/day: improvement of -8.0 (adjusted p-value<0.001, effect size=0.51) in PANSS total scores; improvement of -0.47 (adjusted p-value<0.001, effect size=0.49) in CGI-S scores. Latuda 80 mg/day: improvement of -7.7 (adjusted p-value<0.001, effect size=0.48) in PANSS total scores; improvement of -0.42 (adjusted p-value=0.002, effect size=0.45) in CGI-S scores. Latuda was generally well tolerated in both dose groups. The rate of study discontinuation due to adverse events (AEs) was higher in the placebo vs. Latuda group at 8.0 percent vs 3.7 percent, respectively. Additional data from this study will also be presented, showing that Latuda was associated with minimal changes in weight and metabolic parameters.