FDA FINDS REPLIDYNE, FOREST'S DRUG 'NOT APPROVABLE'

Replidyne and Forest Laboratories announced that the FDA has issued a "not approvable" letter for Replidyne's new drug application (NDA) for faropenem medoxomil, an antibiotic. Replidyne submitted the NDA in 2005 for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections. The NDA was based on the results of 11 Phase III clinical trials for these indications and a safety database of more than 5,000 patients.

According to the letter, the FDA recommends further clinical studies for all indications. For ABS and AECB superiority studies may be needed, and for CAP studies providing additional microbiologic evaluation are required. In its letter the FDA did not raise any safety concerns or chemistry, manufacturing or controls issues related to the product. Replidyne and Forest intend to discuss the clinical plans with the FDA, including the number of trials needed for each indication, and expect that a minimum of two years will be required for completion of the clinical studies.

Historically the FDA has not required superiority design studies such as placebo-controlled studies for approval for antibiotics, but the companies believe that recent public FDA deliberations over the need for placebo-controlled studies for antibiotics were a factor in its decision. Further, recent FDA statements have reflected a preference for superiority studies in ABS, the companies said.

"It is our intention to work together with Replidyne to conduct the additional clinical trials required to obtain FDA approval for at least two respiratory indications in order to launch faropenem. Upon approval, faropenem will be a valuable additional pipeline product for us," Howard Solomon, chairman and CEO of Forest, said.