Aemcolo (Rifamycin SV MMX®)
Aemcolo (Rifamycin SV MMX®) is a pharmaceutical product employing Rifamycin SV engineered with the MMX® technology. Aemcolo is a broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic which has the potential to be used for the treatment of bacterial infections of the colon such as travelers’ diarrhea. The application of MMX technology to Rifamycin SV allows the antibiotic to be delivered directly into the colon, potentially avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. Phase III clinical trials in traveler’s diarrhea have been completed and the NDA has been filed in both the U.S. and EU. On October 23rd, the FDA granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo for the treatment of patients with travelers’ diarrhea. If approved, it is intended that Aemcolo will be initially indicated for the treatment of patients with travelers’ diarrhea and is being studied for IBS-D and uncomplicated diverticulitis.
- Rifamycin SV MMX®