"CDAD is a serious complication for cancer patients and potentially can disrupt the effects of cancer treatment and result in dehydration, impaired functioning, fatigue and, in severe cases, death," said
The analysis assessed treatment outcomes between patients with active cancer and patients without cancer who were treated with either DIFICID or oral vancomycin in two large, pivotal, Phase 3 studies. Results showed that overall, cancer patients with CDAD had slower time to resolution of diarrhea (TTROD) than non-cancer patients (100 hours vs. 55 hours, respectively;
"Fast resolution of diarrhea is critically important for patients undergoing cancer treatment to help resume focus on their primary cancer treatment as quickly as possible," said
Additional results from the retrospective subpopulation analysis that demonstrate the effectiveness of DIFICID in treating CDAD in cancer patients recently were presented at the 22nd
Infections caused by C. difficile and the resulting CDAD pose a significant threat to cancer patients, primarily those with compromised immune systems due to chemotherapy or stem cell transplants. Cancer patients also are at risk for CDAD due to prolonged hospitalization and exposure to antibiotics. In fact, cancer patients with solid tumor or hematologic malignancies account for 16% of hospital CDAD cases.
About the Study
The results are based on two randomized, double-blind, non-inferiority Phase 3 trials conducted at sites in
The subpopulation analysis evaluated the treatment of 183 CDAD patients with active cancer 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. The analysis assessed the number of unformed bowel movements (UBM) per 24 hours to determine time to resolution of diarrhea (TTROD) — defined as the duration of passing UBMs following initial treatment, with an active response considered as < 3 UBM/24 hours. TTROD was defined as hours from first dose of treatment to last UBM on the day preceding two days of < 3 UBM/24 hours.
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 (2%).
Please visit www.DIFICID.com or call 855-DIFICID (343-4243) for full prescribing information for DIFICID.
Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDAD is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDAD, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDAD patients are 65 years of age or older. Historically, approximately 20% to 30% of CDAD patients who initially respond to treatment experience a clinical recurrence.
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to, the potential benefits of DIFICID in treating certain patients and the risk, impact and burden of CDAD. Words such as "believes," "would," "anticipates," "plans," "expects," "may," "intend," "will" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. These forward-looking statements are based on management's expectations on the date of this release. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the possibility of
alternative means of preventing or treating CDAD, whether Optimer will conduct additional clinical trials with respect to DIFICID or whether any such trials will be successful, and other risks detailed in Optimer's filings with the
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