FDA Nodded Sunovion’s Latuda for Bipolar Depression in Pediatric Patients

On March 8, 2018, the U.S. Food and Drug Administration approved the expanded use of the anti-psychotic drug Latuda (also referred to as lurasidone HCI) for a new indication – to treat major depressive episode associated with bipolar depression (disorder) among pediatric patients aged from 10 to 17 years old, as announced by the pharmaceutical manufacturer Sunovion. This is an important milestone for the mental health community, enabling patients to have more treatment options.


Before this new indication was granted, Latuda has already been approved as a prescription medicine used to treat 1) adults and adolescents with schizophrenia aged between 13 and 17; 2) adults, children and teenagers with depressive episodes that happen with bipolar I disorder aged from 10 to 17.


This new indication of Latuda was approved based on a six-week, randomized, double-blind, placebo-controlled study, where 347 children and adolescents aged from 10 to 17 with bipolar depression participated. They received once-daily either Latuda with a flexible dose of 20-80 mg per day or placebo. According to the data patients dosed with Latuda saw a statistically significant and clinically meaningful improvement in bipolar depression symptoms at six weeks compared to placebo. Additionally, Latuda was also seen with 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, comparing with placebo (-1.49 vs. -1.05; effect size = 0.44, p<0.0001).


During the study, Latuda was shown to be generally well-tolerated. Compared to placebo, the most common treatment-emergent adverse events for Latuda were greatly reduced with nausea presenting 16.0% vs. 5.8%, weight gain 6.9% vs. 1.7%, and insomnia 5.1% vs. 2.3%.


As a chronic mental health condition, bipolar disorder can impact people of all ages. This disease is characterized by potentially debilitating severe mood swings that can include periods of depression and mania. In the United States alone, approximately 12.6 million people are affected by bipolar disorder. Of those, about 50 to 66 percent of patients with bipolar disorder experience their first symptoms before the age of 18. In a new announcement released by Sunovion, about 1.7 percent of the pediatric population in the United States is affected by bipolar disorder. But actually this number could be brutally higher as not all cases are included due to diagnosis difficulties.


“Not only in the U.S. but also across the globe, bipolar disorder is a leading cause of disease burden in the pediatric population, but unfortunately, few treatments are effective in treating young people living with the condition,” said Robert Findling, M.D., M.B.A., Vice President of Psychiatric Services and Research at the Kennedy Krieger Institute, Director, Child & Adolescent Psychiatry at the Johns Hopkins University School of Medicine. Generally, children who have been diagnosed with bipolar depression are perceived to be disadvantaged as they are at risk of poor school performance and impairments in social functioning. Thus, it is of huge significance for the FDA to approve Latuda for the treatment of pediatric patients with bipolar depression. The reasons are multi-faceted. First, it offers a new treatment option for this vulnerable group of young people. Second, it is the first single-agent formulation to receive regulatory approval for this pediatric indication.


More about Bipolar Disorder

Bipolar disorder is often characterized by at least one manic or mixed episode throughout one’s lifetime. Bipolar depression refers to the depressive phase of bipolar disorder and individuals often have one or several depressive episodes. The 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. In most cases, symptomatic, depressive symptoms affect patients more commonly than manic symptoms. As a result, bipolar disorder could pose significant impairment for work, family and social interaction.