Zemcolo is a pharmaceutical product employing rifamycin SV engineered with the MMX® technology. Zemcolo is a broad spectrum, semi-synthetic, orally non-absorbable antibiotic which can be used for the treatment of bacterial infections of the colon such as traveler’s diarrhea, infectious colitis, Clostridium difficile associated disease, diverticulitis and also as supportive treatment of Inflammatory Bowel Diseases and Hepatic Encephalopathy. The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Zemcolo tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus abating its systemic absorption in the small intestine.
Phase III clinical trials in traveler's diarrhea have been completed in America and in the EU and the NDA is currently being prepared for filing in both the USA and EU. It is intended that Zemcolo will initially be indicated for the treatment of patients with travelers' diarrhea. In order to expand the indications of the drug, a phase II proof of concept clinical trial is being conducted for non complicated diverticulitis in Europe and a proof of concept dose ranging trial is being conducted with a new formulation in IBSD in Europe as well.
Rifamycin SV MMX® is licensed to Dr. Falk Pharma for Europe.