Optimer's Dificid linked to faster resolution of diarrhoea compared to vancomycin
This article was originally published in Scrip
Executive Summary
A new analysis of the Phase III results has shown that patients treated with its oral antibiotic Dificid (fidaxomicin) saw a speedier resolution of diarrhoea and lower risk of death during the first 12 days of initiation of treatment compared to those treated with ViroPharma's Vancocin (vancomycin). This boosts the company's marketing collateral for Dificid: Earlier this year Optimer gained US approval of Dificid for Clostridium difficile-associated diarrhoea, with superiority language differentiating the medicine from vancomycin, the only other US approved therapy for C. difficile (scripintelligence.com, 1 June 2011).
A new analysis of the Phase III results has shown that patients treated with its oral antibiotic Dificid (fidaxomicin) saw a speedier resolution of diarrhoea and lower risk of death during the first 12 days of initiation of treatment compared to those treated with ViroPharma's Vancocin (vancomycin). This boosts the company's marketing collateral for Dificid: Earlier this year Optimer gained US approval of Dificid for Clostridium difficile-associated diarrhoea, with superiority language differentiating the medicine from vancomycin, the only other US approved therapy for C. difficile (scripintelligence.com, 1 June 2011).
The results, showing a 37% reduction in that composite endpoint through day 12 (p=0.037), were presented at the recent annual meeting of the Infectious Diseases Society of America in Boston. The news 20 October had caused the share price to surge as much as 11.5% before closing at $14.48, a gain of 9.6%; at the end of 21 October the shares were down 1.6% to $14.25.
The Phase III data was originally gained from two prospective, randomised, double-blinded, non-inferiority Phase III trials evaluating Dificid and oral vancomycin in the treatment of C. difficile-associated diarrhoea (CDAD) in adults. Researchers conducted a post-hoc exploratory analysis to determine the time-to-event for a composite endpoint of persistent diarrhoea, disease recurrence, or death of the combined intent-to-treat (ITT) population for the two trials. In the ITT analysis, the superior reduction in persistent diarrhoea or death seen at day 12 for Dificid (p=0.037) was driven by seven deaths among Dificid-treated patients (1.2%) compared to 17 (2.9%) deaths among patients who received vancomycin (exact p=0.06). The overall analysis demonstrated a 40% reduction in persistent diarrhea, disease recurrence or death (all causes) compared to vancomycin through day 40 of the study (p<>