SAN DIEGO--(BUSINESS WIRE)--Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that it plans to begin preparations to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for approval of fidaxomicin as an oral treatment for Clostridium difficile infection (CDI) based on the results from the company’s first Phase 3 CDI trial. The company reported positive top-line results from the first of two Phase 3 trials in November 2008, showing that fidaxomicin met its primary endpoint of clinical cure and showed a significantly lower recurrence rate versus Vancocin® (p=0.004). This trial is the largest single comparative study ever conducted against Vancocin.
