FDA issues not approvable letter for gepirone

HOUSTON, LONDON, and RESEARCH TRIANGLE PARK, N.C. The Food and Drug Administration has issued a not approvable letter for Fabre-Kramer Pharmaceuticals and GlaxoSmithKline’s new drug gepirone extended-release.

The drug is used to treat adults with major depressive disorder. This decision is a result of the FDA reviewing information from a short-term trial it asked the companies to perform after first reviewing the drug in 2004.

The results from the additional trial were submitted to the FDA in May. The FDA made its decision based on the initial clinical data, which had information from Phase I to III data and on the new short-term trial.

The two companies entered into an agreement in February for the worldwide development and commercialization of the drug and are now evaluating the response from the FDA to determine what steps should be taken.