Optimer Pharmaceuticals, Inc. announces the commercial launch of DIFICID (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in patients 18 years of age and older.
In two large Phase 3 clinical studies, DIFICID had clinical response rates at the end of the 10-day treatment period that were non-inferior to oral vancomycin. In addition, DIFICID was superior to vancomycin in sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. With the commercial availability of DIFICID, Optimer is initiating a Patient Assistance Program to help eligible uninsured and underinsured patients gain access to this important treatment option. DIFICID is the only FDA-approved treatment for CDAD that has demonstrated superiority to vancomycin in sustained clinical response and the first new drug approved for the treatment of CDAD in more than 25 years.
More information on the Optimer Patient Assistance Program, including eligibility guidelines, can be accessed from Optimers website at http://www.optimerpharma.com. Patients also can call (855) 841-4236 between the hours of 8 a.m. and 8 p.m. Eastern Standard Time (EST), Monday through Friday to complete the phone application process.
"CDAD can be devastating. The initial disease can be serious, even life-threatening, and about 20 percentÂ to 30 percentÂ may have a recurrence. In some cases, patients have many recurrences. Any treatment that can provide a sustained clinical response is an important advance," says John Bartlett, MD, Stanhope Bayne Jones Professor of Medicine and chief of the Division of Infectious Diseases at the Johns Hopkins University School of Medicine.
Optimer also has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of fidaxomicin, and has entered into an exclusive collaboration and license agreement with Astellas Pharma Europe Ltd. to develop and commercialize the drug in Europe and certain other countries.
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.
Current estimates suggest CDAD may affect more than 700,000 people in the U.S. each year, though the incidence may be higher as many cases are believed to be undiagnosed, untreated and underreported. The disease adds significant costs and burden to the U.S. healthcare system with estimates for medical treatment and hospital stays associated with CDAD reaching as much as $3.8 billion every year. Historically, approximately 20 percentÂ to 30 percentÂ of CDAD patients who initially respond to treatment experience a clinical recurrence.