The US Food and Drug Administration (FDA) has approved Aries Pharmaceuticals’ Aemcolo (rifamycin) 194mg delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for the treatment of adult patients with Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli.
In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo.
With the QDIP designation, intended for antibacterial drugs that treat serious or life-threatening infections, Aemcolo will have marketing exclusivity through 2028. AEMCOLO will be available in pharmacies in the first quarter of 2019.
Travelers’ Diarrhea is the most common and predictable travel-related illness with bacteria accounting for up to 80-90% of cases, the most common of which is enterotoxigenic Escherichia coli (E. coli).
Aries Pharmaceuticals CEO Tom Joyce said: “Travelers’ diarrhea can be highly disruptive and cause significant discomfort for patients, and in some cases, it can progress to more serious conditions if not treated effectively.
“The recent approval of AEMCOLO is an important step for Aries as we continue to grow our portfolio to address important unmet needs in the GI community.”
AEMCOLO was approved based on data from two randomized, multi-center, controlled Phase 3 clinical trials. In both trials AEMCOLO was dosed at 388mg twice daily for three days.
AEMCOLO demonstrated superiority to placebo (p = 0.0008) and non-inferiority to Ciprofloxacin (p=0.0033 for non-inferiority) for the primary endpoint (time to last unformed stool). The most common adverse reactions that occurred in at least 2% of AEMCOLO-treated patients in these clinical trials were constipation and headache (3.5% and 3.3%, respectively).
The University of Texas-Houston School of Public Health’s infectious diseases professor Dr Herbert DuPont said: “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.
“Because AEMCOLO is a minimally absorbed, colon-targeted antibiotic, it will be an important new option for patients.” Dr. DuPont, the founding President of the International Society of Travel Medicine, has studied Travelers’ Diarrhea on four continents for more than 30 years and has been important in establishing the principles of travel medicine.”
Source: Company Press Release