Sunovion Pharmaceuticals Inc. recently issued the following announcement.
"This approval marks an important milestone for the mental health community in Canada, where few approved treatment options are available to adolescents with bipolar depression"
-Sunovion Pharmaceuticals Inc.(Sunovion) announced that Health Canada has approved the Supplemental New Drug Submission (SNDS) that expands the use of Latuda® (lurasidone HCI) 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.
“Given the enormous burden of depression symptoms, and the high rates of suicidality among youth with bipolar disorder, there is an urgent need for treatments that are supported by gold-standard evidence,” said Benjamin Goldstein, M.D., Ph.D., FRCPC, Director of the Centre for Youth Bipolar Disorder at Sunnybrook Health Sciences Centre, and Professor of Psychiatry and Pharmacology at the University of Toronto, Ontario. “LATUDA is a new, effective and generally well-tolerated treatment option for adolescents with bipolar depression, and is a first-line treatment in recent international treatment guidelines. Having evidence-based treatments for bipolar depression in adolescent patients is critically important for the Canadian mental health community.”
The SNDS 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.
“This approval marks an important milestone for the mental health community in Canada, where few approved treatment options are available to adolescents with bipolar depression,” said David Frawley, Executive Vice President, Chief Commercial Officer at Sunovion. “Sunovion is committed to improving the lives of people facing this serious condition, and we are proud that LATUDA can now be considered for use in Canada for adolescent patients in addition to adult patients with bipolar depression.”
Phase 3 Study Results
In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents (10 to 17 years of age) with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or 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 (-21.0 vs. -15.3; effect size = 0.45, p<0.0001). 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) at the secondary endpoint was also seen with LATUDA compared to placebo (-1.49 vs. -1.05; effect size = 0.44, p<0.0001).
LATUDA was generally well-tolerated. The most common treatment-emergent adverse events (TEAEs) reported for LATUDA compared to placebo were nausea (16.0% vs. 5.8%), weight gain (6.9% vs. 1.7%) and insomnia (5.1% vs. 2.3%).
Original source can be found here.