Dainippon Sumitomo Pharma America announced that the FDA has accepted for filing the New Drug Application (NDA) submitted for lurasidone for the treatment of schizophrenia. This submission includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients. In four of these studies, lurasidone demonstrated significantly greater improvement versus placebo on the primary efficacy measure, the Positive and Negative Syndrome Scale (PANSS) total score, at study endpoint.
Lurasidone is an investigational, atypical antipsychotic with high affinities for dopamine D(2), serotonin 5-HT(7), 5-HT(2A), 5-HT(1A), and noradrenaline alpha(2C) receptors and minimal-to-no affinity for histamine H(1) or cholinergic M(1) receptors.
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