Japanese drugmaker Dainippon Sumitomo Pharma Co Ltd. has announced that its Lurasidone, developed for the treatment of schizophrenia has met its clinical trial goals and that the company will submit an application seeking FDA approval for the drug early next year.
In a late-stage clinical trial, findings showed that the drug, when administered in two different doses, performed significantly better than the placebo:
"Both doses of the drug proved to be statistically significantly better than placebo in the primary goal of the study, which was 30 percent or better improvement in the Positive and Negative Syndrome Scale, the company said.
Fifty-three percent of patients who received 40 mg of lurasidone and 47 percent of those on the 120 mg dose achieved the primary goal compared with 38 percent on placebo.
Both doses of lurasidone were also significantly more effective than placebo on a secondary measure used to test antipsychotic drugs called the Clinical Global Impressions Severity scale, the company said."
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