FABRE-KRAMER ANNOUNCES POSITIVE PHASE III RESULTS
Fabre-Kramer Pharmaceuticals has announced the results of its Phase III program for Gepirone ER in Major Depression.
Two double-blind, multicenter, randomized, placebo-controlled clinical studies were conducted in moderately depressed patients. One study, FKGBE007, conducted in 248 depressed patients, met the prespecified endpoint with patients treated with Gepirone ER showing reduced symptoms of depression compared with placebo judged by the physician rated Hamilton Depression Scale.
The results for the secondary endpoints were also statistically significant. The second study, FKGBE008, conducted in 206 depressed patients also showed improvement in depressive symptoms by Week 2 and throughout the study, but failed to reach statistical significance at endpoint. In both studies, the responder rate (patients having a 50 percent decrease in depressive symptoms) was statistically significant for Gepirone ER compared to placebo.
While the first study yielded statistically significant results for Gepirone ER, the second is considered supportive.
The results of these two studies augment earlier positive studies conducted on the drug for major depression and enable Fabre-Kramer to submit an improved set of data to the FDA for review. Later this year, Fabre-Kramer plans to submit an amended new drug application to the FDA.
The majority of adverse events attributable to Gepirone ER treatment in both studies were lightheadedness and nausea, common antidepressant side effects. Accommodation to these adverse events occurred with continued Gepirone ER treatment. Other side effects usual with antidepressant treatment, such as sexual dysfunction, were not seen in Gepirone ER treated patients in either study.