Phase III study of Latuda (lurasidone HCI) shows statistically significant improvement in bipolar disorder- Sunovion Pharma

Sunovion Pharmaceuticals announced that results of a Phase III clinical study evaluating Latuda (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression) showed statistically significant and clinically meaningful improvement in depressive symptoms compared to placebo. Latuda was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on the primary efficacy endpoint of change from baseline to Week 6 on the Children’s Depression Rating Scale, Revised (CDRS-R) total score.

Statistically significant and clinically relevant change from baseline to Week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) was also seen with Latuda compared to placebo. Latuda also demonstrated statistically significant improvement on other secondary efficacy endpoints. Latuda was generally well tolerated.

The most common treatment-emergent adverse events (TEAEs) reported for Latuda compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). The results were presented at the 170th Annual Meeting of the American Psychiatric Association.

These data have been submitted to the U.S. Food and Drug Administration (FDA) to support a supplemental New Drug Application (sNDA).