TORONTO, July 5, 2012 /CNW/ - Optimer Pharmaceuticals Canada, Inc. announced today the approval of DIFICID (fidaxomicin) by Health Canada for the treatment of Clostridium difficile infection (CDI) in patients 18 years of age and older. DIFICID was approved in Canada on a priority basis recognizing the critical need for new options to treat this disease and is the first new treatment for CDI in over 20 years.
Two large double-blind, comparative, randomized clinical studies were conducted with results published in two leading medical journals, The New England Journal of Medicine and The Lancet Infectious Diseases. Over 400 Canadian patients participated in the trials, representing over one third of patients studied. DIFICID was superior to oral vancomycin in reducing CDI recurrence by 46% and shown to be superior in sustaining clinical response for 28 days after treatment i,ii.
DIFICID is the first in a new class of antibiotics called macrocycles. DIFICID targets C. difficile with a high degree of specificity, and has been shown to preserve the normal gut flora, suppress the production of C. difficile toxins A and B, and inhibit the production of C. difficile spores i. "Collectively, these novel effects may contribute to DIFICID's superior efficacy in reducing the risk of CDI recurrence," stated Dr. Wendy Arnott, Executive Director, Scientific Affairs, Optimer Canada.
CDI has a significant burden on the healthcare system iii,iv,v,vi and on the lives of patients and their families suffering from this disease."Clostridium difficile infections (CDI) have been an increasing challenge and burden for the Canadian healthcare system during the last decade vii,viii,ix, and affect the elderly population in a disproportionate manner, iv,v,vii,x " said Dr. Karl Weiss, Professor of Medicine at Maisonneuve-Rosemont Hospital and a member of the Faculty of Medicine at Université de Montréal. "Reducing CDI recurrence is a major objective, knowing that 20 to 30% of affected Canadian patients will experience at least one relapse of the disease, escalating to over 60% after multiple recurrences x." "Today marks a significant advance in the fight against CDI. Awareness of the burden of CDI on the Canadian healthcare system is high with many healthcare providers, patients, and caregivers impacted by this devastating infection, but what is less commonly understood is that CDI is much more than an acute infection. In a significant proportion of patients it is a chronic disease given this high rate of recurrence," said Paulash Mohsen, President and Country Manager for Optimer Canada. "We are proud to have the opportunity to bring this first-in-class antibiotic to help Canadian patients in need."