January 05, 2010
NDA submitted for lurasidone for treatment of schizophreniaDainippon Sumitomo Pharma announced they have submitted a New Drug Application (NDA) to the FDA 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. Specifically, the efficacy of once-daily lurasidone was demonstrated in four six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. These studies included the global PEARL 1 and PEARL 2 clinical trials (Program to Evaluate the Antipsychotic Response to Lurasidone). Clinical trials demonstrated that lurasidone was generally well-tolerated with limited weight gain or changes in metabolic parameters. Furthermore, lurasidone was associated with mild changes in movement disorder parameters and prolactin levels.
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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