Positive data from Phase III study of Dificid/Dificlir (Optimer Pharma) for patients with CDAD

The results of a retrospective subpopulation analysis of 183 patients with cancer from two large Phase III trials of Dificid/Dificlir (fidaxomicin), from Optimer Pharma, which showed the cancer patients with Clostridium difficile-associated diarrhea (CDAD) who were treated with Dificid/Dificlir tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. 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). However, when treatment outcomes were compared between cancer patients receiving Dificid/Dificlir or oral vancomcyin, patients treated with Dificid/Dificlir experienced resolution of diarrhea two days faster than those treated with vancomycin (74 hours vs. 123 hours). The overall safety profile was similar between the Dificid/Dificlir and vancomycin treatment groups. Results will be presented at the 2012 American Society of Clinical Oncology Meeting. Previous results showed that Dificid/Dificlir was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence.