Cosmo Technologies secures FDA approval for Aemcolo to treat travelers’ diarrhea

Cosmo Technologies has achieved a significant milestone with the recent approval from the U.S. Food and Drug Administration (FDA) for its antibacterial drug, Aemcolo (rifamycin). This approval authorizes Aemcolo for the treatment of adult patients suffering from travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), provided the condition is not complicated by fever or blood in the stool.

FDA Approval Highlights

The FDA’s endorsement of Aemcolo specifically targets travelers’ diarrhea linked to noninvasive E. coli strains. The drug’s efficacy was validated through a rigorous randomized, placebo-controlled clinical trial conducted with 264 adults in Guatemala and Mexico. This trial demonstrated that Aemcolo significantly alleviated symptoms compared to a placebo.

Edward Cox, the Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, commented on the approval: “Travelers’ diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition.”

Clinical Trial and Safety Profile

Aemcolo is administered orally over a course of three or four days. The safety of Aemcolo was assessed in two controlled clinical studies involving 619 adults. The most commonly reported adverse effects included headache and constipation.

The FDA has made it clear that Aemcolo is not suitable for patients whose diarrhea is complicated by fever, bloody stools, or caused by pathogens other than noninvasive E. coli. Additionally, the drug is not recommended for those who are hypersensitive to rifamycin or any other components of the drug.

Regulatory Designations and Approval Process

Before receiving FDA approval, Aemcolo was granted the Qualified Infectious Disease Product (QIDP) designation. This status, conferred under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, is reserved for antibacterial and antifungal drugs developed for serious or life-threatening infections. The QIDP designation allowed Aemcolo’s marketing application to be reviewed under Priority Review status, facilitating its expedited approval.