Phase 3 study of lurasidone for schizophrenia

Dainippon Sumitomo Pharma announced positive results from its first Phase 3 study of lurasidone for the treatment of schizophrenia. In this six-week, double-blind, placebo-controlled trial named PEARL 1 (Program to Evaluate the Antipsychotic Response to Lurasidone), lurasidone dosed at 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. Additionally, lurasidone was associated with greater improvement on both the Positive and Negative Syndrome Scale (PANSS) total score (primary endpoint) and the Clinical Global Impressions Severity scale (CGI-S, key secondary endpoint) at all visits between weeks two and six.

Lurasidone is a novel compound with a unique receptor-binding profile including high affinity for dopamine D2, serotonin 5-HT2A, 5-HT7, 5-HT1A, and noradrenalin alpha2c receptors. Lurasidone has low affinity for histamine H1, and cholinergic M1 receptors.

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