FDA Gives QIDP and Fast Track Status To Actelion's Cadazolid For Diarrhea
By Cyndi Root
Actelion Ltd. announced in a press release that the Food and Drug Administration (FDA) has given Qualified Infectious Disease Product (QIDP) and Fast Track status to cadazolid. The agent is indicated for treatment of Clostridium difficile-associated diarrhea (CDAD). The two designations allow the company to communicate more closely with the FDA and to receive priority review upon completion of Phase III IMPACT studies. Guy Braunstein, M.D. and Head of Clinical Development at Actelion said, "Clostridium difficile-associated diarrhea is a very serious and potentially life-threatening infection. There is a great need for an antibiotic that allows effective treatment of CDAD with low recurrence rates, particularly in infections caused by hypervirulent strains. "
Clostridium Difficile
Clostridium difficile is a bacterium that can be life-threatening. Toxigenic strains grow in the colon and often do not respond to antibiotics. In elderly patients, the disease is deadly and represents a major healthcare problem worldwide for all populations. In recent years, new strains have proven even more virulent with diarrhea a serious symptom. Drugs like vancomycin and metronidazole are helpful with cure rates of up to 90 percent but some spores continue to live in the gastrointestinal system and cause re-infection. New drugs are needed that are effective, with low recurrence rates.
Cadazolid
Cadazolid is a novel antibiotic that inhibits C. difficile protein synthesis by suppressing toxins and spore genesis. Studies have shown potent action with low recurrence rates. Due to limited absorption, normal microflora in the gut is negligibly affected. Additionally, the low absorption rate of cadazolid results in a high concentration that allows even diarrhea damaged gut walls to accept the drug treatment.
The IMPACT Studies
IMPACT is an international and multi-center study program for patients with CDAD. Two Phase III studies are comparing cadazolid to vancomycin. Studies began enrollment in 2013 and expect to treat over 1,000 patients. Researchers are looking at safety and efficacy. Specifically, they want to see whether cadazolid is superior to vancomycin.
In Phase II studies, cadazolid proved similar to, or better than vancomycin in clinical cure rates and in sustained cure rates. Clinical cures are defined as cessation of diarrhea with results lasting up to 72 hours. Sustained cures mean no recurrence of CDAD four weeks after treatment.