Published on November 5, 2007 at 4:23 AM
Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.
The FDA had previously reviewed Phase I through III clinical data involving gepirone ER. In June 2004, the FDA requested an additional positive short-term trial in order to consider gepirone ER for approval as a new antidepressant treatment. Subsequently, 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.
Fabre-Kramer and GlaxoSmithKline entered an agreement in February of this year for collaboration on the worldwide development and commercialization of gepirone extended-release tablets. Fabre-Kramer and GSK are evaluating the response from the FDA to determine appropriate next steps.
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