Houston-based Fabre-Kramer Pharmaceuticals has announced positive results for its Phase III studies of Gepirone ER for major depression. Researchers say that one of the studies hit its primary endpoint of reducing symptoms of depression by a statistically significant margin over a placebo. But a second study failed to reach statistical significance.
"Gepirone ER represents the first of a new class of antidepressants, the direct serotonin agonists," said company CEO Stephen J. Kramer. "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."
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