
Forest-Gedeon Richter drug misses overall goal
TEL AVIV (MarketWatch) -- Forest Laboratories Inc. FRX 29.56, +0.37, +1.27%) and Gedeon Richter PLC said Monday that in a Phase II study of cariprazine, a potential treatment for bipolar depression, the overall result for patients taking the drug was not statistically different from that of the patients taking placebo. In higher doses, however, the antipsychotic drug did show "evidence of a clinically relevant treatment effect," the drugmakers, based respectively in New York and Budapest, said. The primary endpoint was the scores on the Montgomery Asberg Depression Rating Scale, they said. The companies are mulling whether to do another Phase II study of the drug to examine a wider range of doses. Meantime, the drug is in Phase III trials for, separately, schizophrenia and bipolar mania
News concerning Tomorrow's FDA decision. This is an antibiotic up for approval up for review tomorrow Sept. 7th, 2010.
FDA Panel Alert: Forest Labs