The Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2018 for a decision on Aemcolo (rifamycin SV MMX; Cosmo Pharmaceuticals), a treatment for travelers’ diarrhea (TD). 

Aemcolo is a broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic intended to treat patients with travelers’ diarrhea. The tablet is manufactured with the Company’s Multi Matrix MMX technology, designed to deliver active pharmaceuticals into the lumen in a delayed fashion that applies the ingredients to the full length of the colon. 

Last October, the treatment was granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA. A Phase 3 clinical trial of patients with travelers’ diarrhea demonstrated that Aemcolo was superior to placebo (P=.0008) and non-inferior to ciprofloxacin

“Resistance to currently available antibiotics is a serious issue and there have been no new chemical entities approved to treat colonic infections in more than 10 years,” said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals. “We look forward to productive interactions with the FDA as we work to bring Aemcolo to patients.” 

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