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Fidaxomicin minimally absorbed, even in severe C. difficile
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Data from two phase 3 trials indicate that fidaxomicin is minimally absorbed in patients with Clostridium difficile, according to data presented here.
In two double blind, randomized controlled clinical trials, Pamela S. Sears, PhD, executive director of biology and preclinical science at Optimer Pharmaceuticals Inc., and colleagues compared oral fidaxomicin (200 mg, every 12 hours) with oral vancomycin (125 mg, every 6 hours) for 10 days in 1,164 patients with C. difficile infection.
The researchers collected plasma samples before each dose and 3 to 5 hours after; fecal samples were collected at the end-of-therapy visit.
Plasma concentrations were low for fidaxomicin, with an average of 22.8 ng/mL on day 1 and 28.5 ng/mL at end of therapy. The metabolite OP-1118 averaged 44.5 ng/mL on day 1 and 85.6 ng/mL at end of therapy. Fecal concentrations were more than 1,000 mcg/g for fidaxomicin; and fecal levels exceeded 800 mcg/g for OP-1118.
“Following oral administration, [fidaxomicin] has minimal systemic exposure, even in patients with [C. difficile infection],” Sears said in a press release. “These data show that [fidaxomicin] tends to stay in the site of infection for this disease.”
For more information:
- Sears PS. #Mo1160. Presented at: Digestive Disease Week 2011; May 7-10; Chicago
Disclosure: Dr. Sears is an employee at Optimer Pharmaceuticals Inc.
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