20 April 2018 - Sunovion today announced that Health Canada has approved the supplemental new drug submission that expands the use of Latuda (lurasidone hydrochloride) to include the acute management of depressive episodes associated with bipolar I disorder in adolescents (13 to 17 years of age).

Latuda is currently indicated in Canada for the management of the manifestations of schizophrenia in adults and adolescents (15 to 17 years of age) and the acute management of depressive episodes associated with bipolar I disorder in adults.

The submission is supported by data from a Phase 3 clinical study of children and adolescents (10 to 17 years of age) with bipolar depression. In this study, Latuda was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo and was generally well-tolerated.

Read Sunovion Pharmaceuticals press release