Access Pharmaceutical, Inc. (ACCP) and MacroChem Corp. (MACM) announced that the results of two Phase 3 studies of pexiganan for the topical treatment of mild diabetic foot infection were published in the December 15, 2008 issue of Clinical Infectious Diseases. The authors concluded that based on the data from these Phase 3 studies, topical pexiganan might be an effective alternative to oral antibiotic therapy in treating diabetic patients with a mildly infected foot ulcer, and might reduce the risk of selecting antimicrobial-resistant bacteria.
Although study 303 failed to demonstrate equivalence, study 304 and the combined data for the 2 trials demonstrated equivalent results (within the 95% confidence interval) for topical pexiganan and oral ofloxacin in clinical improvement rates (85%-90%), overall microbiological eradication rates (42%-47%), and wound healing rates. The incidence of worsening cellulitis (2%-4%) and amputation (2%-3%) did not differ significantly between treatment arms. Bacterial resistance to ofloxacin emerged in some patients who received ofloxacin, but no significant resistance to pexiganan emerged among patients who received pexiganan.
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