Pfizer Inc said that its novel antibiotic Zyvox (linezolid injection, tablets and for oral suspension) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic foot infections, without osteomyelitis, caused by Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). Zyvox is the first and only oral antibiotic approved for the treatment of MRSA infections.

Foot ulcer is a potentially serious complication that threatens an estimated 15 percent of the 17 million people with diabetes in the United States. Among diabetes patients who develop a foot ulcer or wound, approximately six percent will be hospitalized because of the infection or other ulcer-related complications. Serious infections can lead to long-term debilitation and, in the most severe cases, amputation. Diabetes is the leading cause of non-traumatic lower extremity amputations in the United States.

"It is critically important that healthcare professionals who treat people with diabetes be aware of their patients' risk for foot infections, especially those caused by resistant bacteria, and of available therapies," said Dr.David G. Armstrong, a member of both the American Podiatric Medical Association's Diabetes Advisory Committee and the national board of directors of the American Diabetes Association.

The most commonly used antibiotics to treat diabetic foot infections are aminopenicillin/beta-lacatamase inhibitors such as ampicillin-sulbactam (IV) and amoxicillin-clavulanate. However, when MRSA is the suspected pathogen, vancomycin (IV) is usually added to the regimen.

"The approval of Zyvox for treatment of diabetic foot infections fills an unmet medical need for an oral treatment for these patients who are at an increased risk of getting an infection caused by MRSA," said Dr. Benjamin Lipsky, Professor of Medicine at the University of Washington School of Medicine. "The availability of an orally administered treatment is important because it may reduce the need for hospitalization as well as IV-related complications," he said.

The basis for the approval of Zyvox to treat diabetic foot infections was a linical trial conducted at 30 U.S. and 15 European sites. Data demonstrated that Zyvox was as effective as two standard aminopenicillin therapies in treating diabetic foot infections caused by Gram-positive bacteria.