Sunovion announced the results of its Phase 3 study of Latuda (lurasidone HCI) in children aged 10 to 17 years with depression associated with bipolar I disorder.
Latuda is currently indicated to treat major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate, in adults. It is also indicated for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years.
The Phase 3 study was a double-blind, placebo-controlled, parallel-group, multi-regional study which lasted 6 weeks. Participants were randomized to receive once-daily Latuda flexibly dosed (20-80mg/day) or placebo. The primary efficacy endpoint was change from baseline to Week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score, and the key secondary endpoint was change from baseline to Week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score for depression.
At both the primary and key secondary endpoints at Week 6, treatment with Latuda was associated with statistically significant and clinically meaningful improvement in symptoms of bipolar depression compared to placebo.
“We are encouraged by these topline results that demonstrate the potential of Latuda to help children and adolescents with bipolar depression,” said Antony Loebel, MD, EVP and CMO of Sunovion. The company intends to submit a supplemental New Drug Application (sNDA) for Latuda as a treatment for children and adolescents aged 10 to 17 years with bipolar depression.
The full results from the trial are being analyzed and will be presented at upcoming scientific meetings.
For more information visit Sunovion.com.