The FDA has issued Replidyne and partner Forest Labs a non-approvable letter for faropenem medoxomil, an antibiotic for acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis and adult skin infections. The FDA called for further trials of the drug, despite the fact that researchers went to the NDA with data from 11 Phase III trials involving 5,000 patients. Replidyne says that it has apparently fallen victim to the FDA's recent preference that drug developers prove that their antibiotics are superior to standard care, not just placebos. They estimate that the additional trials will take two years to complete. No safety concerns were raised by the FDA.
"Based on the filing packages we included in our NDA submission, particularly for ABS and CAP, we are disappointed that the FDA is requiring additional clinical trials," said Kenneth J. Collins, President and CEO of Replidyne in a release. "However, we believe that at the doses studied faropenem has a clearly demonstrated favorable safety profile. Replidyne is in a strong financial position to continue the development of faropenem with our partner Forest and to advance our promising pipeline." As you might recall, Replidyne was chosen as a 2006 Fierce 15 company.
- see this press release from Replidyne
- read the Houston Chronicle report