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news.Dainippon Sumitomo Pharma (DSP) has reported that Latuda has met the primary and secondary endpoints in two Phase III trials in Bipolar I Depression.
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As measured by the Montgomery-Asberg Depression Rating Scale, the bipolar I depression patients treated with Latuda experienced statistically significant improvements in symptoms of depression compared to patients taking placebo.
The patients in the Latuda treatment arms experienced low changes in weight, lipids and measures of glycemic control, on an overall basis, in both the trials.
Dainippon Sumitomo Pharma president and chief executive officer Masayo Tada said, "With both studies meeting their primary endpoints, we remain on track to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for LATUDA in bipolar I depression by the end of 2012."
Latuda is approved by the FDA in the US for the treatment of adult patients with schizophrenia.