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Optimer Pharmaceuticals, Inc. Announces Presentation at ECCMID of Post-Hoc Subgroup Analysis of DIFICID in Adult Cancer Patients Being Treated for Clostridium difficile-Associated Diarrhea (CDAD)
Date:3/30/2012

ment of CDAD in adults.  These studies served as the basis of approval for DIFICID by the U.S. Food and Drug Administration (FDA) in May 2011.

The subgroup analysis evaluated the treatment of 183 CDAD patients with active cancer – 153 of whom received 8 days or more of treatment – compared to 922 CDAD patients without cancer who were among the modified intent to treat population of the Phase 3 studies (N=1105).  To be included in the analysis, patients must have had a current diagnosis of cancer at the time of CDAD diagnosis and were receiving various forms of treatment. Patients with active cancer (solid tumor or hematologic malignancy) were identified from medical history, concomitant medication indications, and adverse event entries in the case report forms. Clinical endpoints assessed in the 153 patients, included clinical cure at the end of treatment, recurrence of CDAD after clinical cure during the four week follow-up, and sustained clinical response (clinical cure with no recurrence in the four-week follow-up period).

About DIFICID® (fidaxomicin) Tablets
DIFICID is the first antibacterial drug indicated for Clostridium difficile-associated diarrhea (CDAD) to be approved in more than 25 years. It is indicated for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 mg tablets given orally twice daily.

Important Safety Information for DIFICID
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia
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SOURCE Optimer Pharmaceuticals, Inc.
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