Dainippon readies NDA after schizophrenia trial delivers

Researchers for Japan's Dainippon Sumitomo say that a second late-stage trial offered convincing data that their experimental drug lurasidone controls symptoms for schizophrenia without some of the serious side affects that afflict some patients taking competing drugs. And that positive outcome has set the stage for an FDA marketing application in early 2010 as the company prepares to start selling its first drug in the U.S.--with hopes of achieving blockbuster status.

Lurasidine is designed to work much like Zyprexa, Risperdal or Seroquel, without the weight gain that many patients experience. And the Japanese company is also testing the therapy as a treatment for bipolar disorder. Analysts expect the drug's safety profile will allow it to break the billion-dollar barrier in the U.S. if it is approved.

Working with a commonly used score card on side effects, the latest clinical trial demonstrated that both a 40 mg and 120 mg dose significantly lowered incidents when compared to the experiences of patients taking a placebo. In an earlier late-stage trial only the 80 mg dose outperformed a placebo.

"If you look at the weight gain, the lipid changes, it's among the most benign of any antipsychotic drugs, clearly better than olanzapine, clozapine and Seroquel," says Vanderbilt's Dr. Herbert Meltzer, a lead investigator.

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