Drugs

Guide on Diabetic Foot Infection Drugs

FDA has posted a final guidance entitled “Diabetic Foot Infections (DFI): Developing Drugs for Treatment.” The document addresses the agency’s current thinking regarding the overall development program and clinical trial designs for developing drugs to support an indication for treating DFI.

FDA says that important considerations for developing such treatments include the types of bacteria that are associated with DFI, which can be either monomicrobial or polymicrobial. “Monomicrobial infections with aerobic gram-positive cocci such as Staphylococcus aureus or β- hemolytic streptococci typically occur in patients who have not recently received antibacterial therapy,” the guidance says. “Patients who have chronic wounds or who have recently received antibacterial therapy are more prone to developing polymicrobial infections. These infections can involve pathogens such as aerobic gram-positive cocci, including methicillin-resistant Staphylococcus aureus, and gram-negative organisms, including drug-resistant gram-negative pathogens. Patients with limb ischemia or necrotic wounds may be infected by anaerobic pathogens.”

Additionally, the agency says the drug development population should include subjects with diabetes mellitus who have a bacterial infection of the foot, located at or distal to the malleoli. Regarding efficacy considerations, the guidance says noninferiority (NI) trials are acceptable to support approval for a DFI indication, provided an acceptable NI margin is clearly justifiable. “Superiority trials comparing the investigational drug to an active control are also readily interpretable and provide direct evidence of treatment benefit,” it says.

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