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Fabre-Kramer Announces Positive Phase III Results for Gepirone ER in Major Depression Program

HOUSTON, June 29, 2005 PRNewswire-- Fabre-Kramer Pharmaceuticals, Inc. announced today the results of its Phase III program for Gepirone ER in Major Depression. Two double-blind, multi-center, randomized, placebo-controlled clinical studies were conducted in moderately depressed patients. One study, FKGBE007, conducted in 248 depressed patients, met the pre-specified endpoint with patients treated with Gepirone ER showing reduced symptoms of depression compared with placebo judged by the physician rated Hamilton Depression Scale, p=0.032. 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% 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 NDA to the FDA. Stephen J. Kramer, M.D., CEO, stated, "Gepirone ER represents the first of a new class of antidepressants, the direct serotonin agonists. Working by a new mechanism of action, Gepirone ER, if approved, could provide a new treatment modality for depressed patients who are not helped by currently available treatments."

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.

If approved for commercialization by FDA, Fabre-Kramer expects Gepirone ER to compete favorably in the $20 billion world-wide antidepressant market.

About Fabre-Kramer
Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texas is engaged in acquiring, developing and commercializing psychotropic drugs that have significant market potential. In addition to Gepirone ER, Fabre-Kramer has 10 other compounds in various stages of development for indications including depression, anxiety, schizophrenia, Parkinson's disease and insomnia.