Latuda, the antipsychotic agent, has been marketed for the treatment of schizophrenia in Canada by Sunovion Pharmaceuticals Canada, a subsidiary of the US-based Sunovion Pharmaceuticals.
The company said that an application for the additional indications was submitted in August 2012 for review by the Health Canada.
The new indication is supported by two double-blind, placebo-controlled, six-week Phase III clinical trials (PREVAIL 1 and PREVAIL 2).
Both trials demonstrated that treatment with Latuda resulted in statistically significant and clinically meaningful reductions in the major endpoint of the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6, with significant separation from placebo observed as early as Week 2 of treatment.
In both the trials, patients treated with Latuda experienced low rates of change in weight, body mass index (BMI), lipid parameters and measures of glycemic control.
DSP expects that Latuda will contribute to the treatment of patients suffering from depressive symptoms associated with bipolar I disorder (bipolar depression) in Canada.
Lurasidone HCl is a new atypical antipsychotic developed originally by DSP and it was approved by the US Food and Drug Administration (FDA) in October 2010 for schizophrenia, and it was launched in February 2011 under the brand name Latuda.
In June 2013, FDA had approved additional indications for the use of Latuda for the treatment of bipolar I disorder (bipolar depression).
In June 2011, the company had filed the New Drug Submission (NDS) for Latuda in Canada and was approved by in June 2012 for the treatment of schizophrenia while its market launch was done in September 2012.
Image:Dainippon Sumitomo Pharma headquarters located in Osaka, Japan. Photo: courtesy of Kirakirameister