FDA Greenlights sNDA Submission for Lurasidone Hydrochloride to Include Pediatric Patients

The US Food and Drug Administration (FDA) approved the submission of a supplemental New Drug Application (sNDA) from Sunovion Pharmaceuticals for its lurasidone hydrochloride (Latuda) to include the treatment of major depressive episodes associated with bipolar I disorder in pediatric patients aged 10 to 17 years.

The therapy is currently approved for use by adults with bipolar depression as a monotherapy, as well as in conjunction with lithium or valproate, and for the treatment of schizophrenia in patients aged 13 and older.

Bipolar disorder is a leading cause of disease burden in the pediatric population both here in the U.S. and across the globe, but unfortunately, few treatments are effective in treating young people living with the condition,” Robert Findling, MD, MBA, said in a statement. “We know that children who have been diagnosed with bipolar depression can be at risk for poor school performance and impairments in social functioning.”

The sNDA approval was given with supportive data from a 6-week, phase 3 clinical trial of 347 children and adolescents aged 10 to 17 years with bipolar depression. The study data revealed statistically significant and clinically meaningful improvement of bipolar I depressive symptoms compared with placebo, according to Sunovion.

Data showed that patients on once-daily lurasidone hydrochloride, flexibly dosed (20—80 mg) experienced mean basal changes in Children’s Depression Rating Scale, Revised (CDRS-R) total scores of –21.0 by week 6 compared to –15.3 with placebo (effect size, 0.45; P <.0001).

Additionally, change from baseline to week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score—the secondary endpoint&mdash;was also seen with the Sunovion product compared to placebo (—1.49 vs. –1.05; effect size, 0.44; P <0001).

The therapy was also well tolerated. The most common adverse events (AEs) were nausea at 16.0% with lurasidone hydrochloride (5.8% with placebo), weight gain (6.9% compared to 1.7%), and insomnia (5.1% compared to 2.3%).

“The FDA approval of this medicine for the treatment of pediatric patients with bipolar depression is significant for several reasons,” Findling, the vice president of Psychiatric Services and Research at the Kennedy Krieger Institute, and the director of Child & Adolescent Psychiatry at the Johns Hopkins University School of Medicine, said. “First, it is a new treatment option for this vulnerable group of young people. Also, it is the first single-agent formulation to receive regulatory approval for this pediatric indication.”

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