Optimer Launches Patient Assistance Program for Clostridium Difficile-Associated Diarrhea (CDAD)

July 18, 2011

Optimer Pharmaceuticals, Inc. has announced the commercial launch of DIFICID™ (fidaxomicin) tablets for treating Clostridium difficile-associated diarrhea (CDAD) in patients aged 18 years 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.

“CDAD can be devastating. The initial disease can be serious, even life-threatening, and about 20 to 30% may have a recurrence. In some cases, patients have many recurrences. Any treatment that can provide a sustained clinical response is an important advance,” said John Bartlett, M.D., Stanhope Bayne Jones Professor of Medicine and Chief of the Division of Infectious Diseases at The Johns Hopkins University School of Medicine.

Optimer’s Patient Assistance Program

With the commercial availability of DIFICID, Optimer is starting a Patient Assistance Program to help uninsured and underinsured patients obtain the treatment option.  

According to the company, patient access to DIFICID is its highest priority, and the Patient Assistance Program will help to expand access.

For more information about the Patient Assistance Program, including eligibility guidelines, visit Optimer’s website at http://www.optimerpharma.com.  Patients can also call (855) 841-4236 to complete a phone application process.

Important Safety Information about DIFICID

DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.

The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).

For full prescribing information for DIFICID, please call 1-855-DIFICID (1-855-343-4243) or visit www.DIFICID.com.

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