July 05, 2012 - 12:37 PM
TORONTO - Health Canada has approved a new drug for the treatment of C. difficile diarrhea.
The antibiotic has been shown in clinical testing to reduce the risk of recurrent bouts of diarrhea in people suffering from C. difficile.
The drug's generic name is fidaxomicin; it will be sold under the brand name Dificid by its maker, Optimer Pharmaceuticals Canada.
A clinical trial conducted in Canada showed the drug was as effective as the current treatment, vancomycin, as therapy for Clostridium difficile diarrhea.
But the research, which was funded by Optimer, also showed some people treated with fidaxomicin were substantially less likely to have a recurrence of C. difficle than people treated with vancomycin.
In fact, about 15 per cent of people on fidaxomicin had a recurrence, as compared with 25 per cent among people treated with vancomycin.
However, the lower rate of recurrence was not seen in people infected with a severe strain of C. difficle that has been spreading over the past decade or so.
There was no difference in recurrence rates between fidaxomicin and vancomycin for patients infected with the so-called NAP-1 — sometimes called 027 — strain, according to the clinical trial, which was published last year in the New England Journal of Medicine.
According to the study, there were no significant differences between the two drugs when it came to rates of adverse events.
A spokesperson for Optimer says the drug will sell for $2,200 for a 10-day course.
Between 20 and 30 per cent of people who develop C. difficile diarrhea will have a recurrence after receiving their initial treatment with antibiotics.
News from © The Canadian Press, 2012