FDA Approval For New Drug Treating Hospital Scourge

The Event That Lead To The Research
In 1971, Dr. Sherwood L. Gorbach who was a researcher in infectious diseases received an emergency call for assistance from a drug company. The company’s antibiotic medicine that had been administered to some patients in a hospital in New Zealand had developed complications. Many of the patients treated with the drug developed severe diarrhea and inflammation of the bowel, which had caused some deaths. Dr. Gorbach since then dedicated his research to finding the cause of the complication and trying to find a treatment for the outbreak. After over four decades of research, the Foods and Drug Administration has approved his new drug.

The New Drug Dificid
Dr. Gorbach’s new drug known as Dificid is the first drug that has been approved in the last twenty-five years to treat diarrhea. The new drug is effective to cure diarrhea caused by Clostridium difficile, which is a bacterium that is one of the leading causes of infections caused in the hospitals. During the clinical trials, the new drug also known as fidaxomicin, was found to be more effective than the other approved medicine that keeps patients free of the symptoms twenty-five days after the completion of the treatment. Dr. Gorbach who is seventy-six years is the chief scientific researcher with Optimer Pharmaceuticals, which is the company that developed the drug.

Deaths Due To Difficile Have Seen An Increase
C. difficile, which means difficult, the primary bacterium for the diarrhea has seen an increase in the infections caused and resultant deaths. The primary reason for this increase witnessed sine 1990 is the spread of a more virulent strain. According to estimates, there are thousands of American citizens infected by the bacterium. Among the infected patients, nearly one percent needs surgery to remove their colons while roughly five percent of the infected patients die each year. Although, a large percentage of the infected population includes senior citizens in hospitals, there are cases where adults and children are also infected. Moreover, several cases are detected outside the hospitals.

Cause For Hospital Infections
When a patient is administered with an antibiotic for treating an infection, there is a possibility of destroying other harmless bacteria present in the intestines. This enables C. Difficile that resides within to emerge, as it is resistant to almost all the antibiotics. Two drugs are used to treat C. Difficile. The first is Flagyl (this has not been approved). The other drug is Vancocin, which is an oral form of the antibiotic known as vancomycin (this was approved by the FDA in 1986). While the treatment helps overcome the diarrhea, the possibility of its recurrence is high. After being discharged, the diarrhea often recurs effectively rendering the entire treatment as pointless. The new drug developed by Dr. Gorbach will help prevent these recurrences.

Dificid More Effective Than Vancocin
A clinical trial with over 1100 patients who were treated with Dificid and Vancocin, it was found that almost 85% of the patients were cured of diarrhea within the ten-day treatment period. However, a vast difference was seen in the recurrences. Almost 25% of the Vancocin patients had the diarrhea recur in comparison to only 15% recurrences with Dificid.