FDA Approves New Drug To Treat Clostridium Difficile Infections
Posted May 29 2011 1:59am
In July of 2010 the FDA approved a test for C Diff and the results are given within an hour. Already launched in Europe, illumigene C. difficile uses technology that makes it easier and less expensive to use than some other molecular tests.
In a related FDA approval and injectable gel has been approved that could be used in conjunction with the C Diff infections.
The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed. Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence. The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.
Dificid is a macrolide antibacterial, should be taken two times a day for 10 days and is made by Optimer Pharmaceuticals. If all else fails, there’s the last resort with feces donors. BD
FDA approves treatment for Clostridium difficile infection The U.S. Food and Drug Administration today approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea and lead to colitis, other serious intestinal conditions, and death in severe cases. C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths.
The safety and efficacy of Dificid were demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.
“In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea.”