The Food and Drug Administration (FDA) had previously reviewed Phase I through III clinical data involving gepirone extended release (ER). In June 2004, the FDA requested an additional positive short-term trial in order to consider gepirone ER for approval. Subsequently, Fabre-Kramer (FKP) successfully conducted a trial in patients with major depressive disorder to respond to the FDA request for an additional positive pivotal study.
Those results were submitted to the FDA in May 2007. The not approvable letter issued today is based on the FDA review of those additional results along with other newly submitted and previously submitted data.