ARTICLE | Clinical News

Fabre-Kramer gepirone Phase III data

June 30, 2005 1:33 AM UTC

Fabre-Kramer (Houston, Texas) said its gepirone ER met the primary endpoint in one U.S., double-blind Phase III trial but missed the endpoint in another to treat major depression. In the FKGBE007 trial in 248 patients, gepirone ER significantly reduced depressive symptoms as measured by the Hamilton Depression Scale compared with placebo (p=0.032). In the FKGBE008 trial in 206 patients, the partial serotonin (5-HT1A) receptor agonist improved depressive symptoms, but failed to reach statistical significance at week eight. ...