US-based biopharmaceutical company Sunovion Pharmaceuticals has reported positive top-line results from its Phase III clinical trial of latuda (lurasidone HCl) for the treatment of depression associated with bipolar I disorder (bipolar depression).
Latuda is a part of atypical anti-psychotics class, which are thought to work by modifying the levels of neurotransmitters dopamine and serotonin.
It is being developed to treat patients with bipolar depression when used alone or with lithium or valproate in adults, as well as schizophrenia in adults and adolescents 13 to 17 years of age.
The results from the trial showed statistically significant and clinically meaningful improvement in symptoms of bipolar depression when compared to placebo, at both the primary and secondary endpoints.
The randomised, double-blind, placebo-controlled, parallel-group, multi-regional Phase III trial evaluated latuda for six weeks, in children and adolescents aged 10 to 17 years with bipolar depression.
Sunovion executive vice-president and chief medical officer Antony Loebel said: “There are few treatment options for bipolar depression in this population.
“We are encouraged by these top-line results that demonstrate the potential of LATUDA to help children and adolescents with bipolar depression.”
The trial's primary efficacy endpoint was change from baseline to week six on the children depression rating scale revised (CDRS-R) total score, while the secondary endpoint was change from baseline to week six on the clinical global impression-bipolar version, severity of illness (CGI-BP-S) score for depression.
Latuda was found to be generally well tolerated, with minimal effects on weight and metabolic parameters.