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FDA fast-tracks Aemcolo for travelers’ diarrhea

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FDA has granted Cosmo Pharmaceuticals fast track and qualified infectious disease product designations for Aemcolo, an investigational treatment for patients with travelers’ diarrhea, according to a recent press release.

“There have not been any new chemical entities approved to treat colonic infections in years, so resistance to current available drugs is a serious issue,” Alessandro Della Chà, CEO of Cosmo Pharmaceuticals, said in the press release. “The [qualified infectious disease product (QIDP)] and fast track designations highlight the importance of treating colonic infections with new chemical entities and Aemcolo’s potential to address this unmet medical need.”

The phase 3 clinical trials of Aemcolo (Rifamycin SV MMX) in travelers’ diarrhea, completed in the U.S. and the European Union, have demonstrated Aemcolo’s superiority over placebo (P = .0008) and its non-inferiority compared with ciprofloxacin, per the press release. Cosmo and its subsidiary, Aries Pharmaceuticals Inc., will lead the commercial sales and marketing for Aemcolo in the U.S., focusing on creating a portfolio of therapies to improve certain gastrointestinal disorders and endoscopic procedures.

Aemcolo’s fast-track designation means it is eligible for priority review and if approved, it will be eligible for 5 more years of market exclusivity based on the QIDP designation, according to the release. Currently, the company is preparing new drug and marketing authorization applications for submission to the FDA and European Medicines Agency for Aemcolo, per the release.

“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,” Tom Joyce, CEO of Aries Pharmaceuticals, said in the release. “Aemcolo has the potential to be an excellent fit with our portfolio of novel products that address high unmet needs for physicians and patients in diagnosing and treating gastrointestinal disorders.”

Disclosures: Chà is employed by Cosmo Pharmaceuticals. Joyce is employed by Aries Pharmaceuticals.