A new drug produced by Optimer called Dificid, is the first new medicine in 25 years approved to reduce diarrhea caused by Clostridium difficile (C. difficile or C. diff), a bacterium that some studies suggests may have surpassed the better known MRSA as the leading hospital acquired infection. Dificid is the first drug Optimer has had approved in its history.
Problems usually start when people are treated with antibiotics for some other infection. That can kill off many of the harmless bacteria in the intestines, allowing C. difficile, which is resistant to most antibiotics much like MRSA, to take over the body.
C-diff is a spore-forming bacterium that was discovered in 1978 to be the cause of antibiotic-associated diarrhea and colitis. It is rapidly spreading through health-care facilities around the globe. When the normal bacteria that live in the colon are disturbed, usually as a result of antibiotic treatment, and a patient ingests C-diff spores, the bacteria can multiply and release the two toxins.
C-diff sickens about 500,000 Americans a year, contributing to 15,000 to 20,000 deaths, The epidemic strain has been found in 38 states, including Illinois. It now rivals the superbug known as MRSA as one of the top emerging disease threats to humans. Since its discovery, C-diff has grown increasingly resistant to antibiotics. Though it is appearing more often in younger people, those 65 years and older face a greater risk of developing infection from C-diff and has more severe outcomes and higher death rates.
Dificid, also known as fidaxomicin, proved better than the only approved drug in keeping patients free of symptoms 25 days after the end of treatment.
Read the full 128 page briefing document that influenced the FDA’s decision
Infections and deaths from C. difficile have increased sharply since the 1990s, in part because of the spread of a more virulent strain. It is estimated that several hundred thousand Americans are infected each year. Up to 1% of patients must have their colons removed and about 5% die.
In two clinical trials involving a total of about 1,100 patients, both Dificid and Vancocin cleared the diarrhea in more than 85% of patients by the end of the 10-day treatment period. But in later weeks, roughly 25% of the Vancocin users had a recurrence compared with only about 15% of the Dificid users. Vancocin, by Eli Lilly really started hitting the global market in 2004.
The bottom line is that 25 days after the end of treatment, about 70% of those treated with Dificid were still free of disease compared with 57% of those treated with Vancocin, according to Dificid’s label.
Vancocin had sales of $259.6 million in 2010, up 22% because of price increases, while the number of prescriptions declined. Dificid is predicted to pull in $160 million by 2015. The new drug is likely to be at least as expensive as Vancocin, which costs $1,000 or more for a course of treatment.
Symptoms of C-diff include profuse diarrhea and abdominal pain and distention of the abdomen. An infection is also frequently accompanied by fever, nausea and dehydration. In some rare cases blood may be present in the stool. The infection is spread by spores that contaminate the hospital environment and hands of healthcare workers who can transmit the spores to patients. The resistance of the spores to hospital cleaning agents and to alcohol hand disinfectants makes it extremely difficult to eradicate.
Sources: Optimer and
Written by Sy Kraft