Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded use of Latuda (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy.

LATUDA is currently indicated in the U.S. for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate and for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age).

"Bipolar depression is a severe and disabling condition, yet few treatment options are available for children and adolescents with this disorder," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "We look forward to working closely with the FDA toward the goal of offering a new treatment option for this difficult to treat condition."

The sNDA is supported by data from a Phase 3 clinical study of children and adolescents (10 to 17 years of age) with bipolar depression, in which LATUDA was associated with statistically significant and clinically meaningful improvement in depressive symptoms compared to placebo and was generally well-tolerated with few effects on weight and metabolic parameters.

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) was also seen with LATUDA compared to placebo (-1.49 vs. -1.05; effect size = 0.44, p<0.0001). LATUDA also demonstrated statistically significant improvement on other secondary efficacy endpoints.

Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania. It affects approximately 12.6 million adults in the United States. Approximately 50 to 60 percent of adults with bipolar disorder experience their first symptoms during adolescence and it can be difficult to diagnose. Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States. Symptoms of bipolar disorder in children and adolescents can be severe and may cause young people to think about death or suicide during depressive episodes.

Bipolar disorder is the fourth leading cause of disability among children and adolescents worldwide. Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes. Bipolar depression refers to the depressive phase of bipolar disorder; its symptoms include: depressed mood, loss of interest or pleasure in activities, significant weight loss, insomnia, fatigue, feelings of worthlessness, diminished ability to concentrate and recurrent thoughts of death or suicide attempt. When symptomatic, depressive symptoms affect patients more commonly than manic symptoms. Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function, and are associated with increased risk of suicide and direct and indirect health care costs.