FDA Approves New Treatment for Travelers' Diarrhea
Aemcolo is a broad spectrum, semi-synthetic, orally-administered, minimally-absorbed antibiotic.
The Food and Drug Administration (FDA) has approved Aemcolo (rifamycin; Aries Pharmaceuticals) for the treatment of adults with travelers' diarrhea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
Aemcolo is a broad spectrum, semi-synthetic, orally-administered, minimally-absorbed antibiotic designed to allow for delayed release to the colon. The approval was based on data from two Phase 3 trials in which treatment with Aemcolo was found to be superior to placebo (P=.0008) and non-inferior to ciprofloxacin (P=.0033 for non-inferiority); the primary endpoint of the studies was time to last unformed stool. With regard to safety, the most common adverse reactions associated with Aemcolo included constipation and headache.
"Given the potential seriousness of travelers' diarrhea and growing resistance to antibiotics that have been in widespread use since the early '90s, it's important to have new options for treatment," said Herbert L. DuPont, MD, Professor of Infectious Diseases at The University of Texas-Houston School of Public Health and primary investigator. "Because Aemcolo is a minimally absorbed, colon-targeted antibiotic, it will be an important new option for patients."
Aemcolo is expected to be available in 194mg delayed-release tablets in the first quarter of 2019.
For more information visit ariespharma.com.