PHARMACY

Study shows ‘good’ bacteria in colon fights toxins associated with antibiotic use

BY Michael Johnsen

SAN BRUNO, Calif. A new study released Wednesday by the Association for Professionals in Infection Control and Epidemiology has found that 13 out of every 1,000 patients were either infected or colonized with Clostridium difficile, a severe intestinal disease that continues to be the subject of heightened concern in the medical community.

“Clostridium difficile is a gram-positive anaerobic bacterium that can enter and exist in the human colon, but it is usually held in check by normal intestinal flora, or ‘good’ bacteria,” said Patricia Raymond, gastroenterologist and associate professor of clinical medicine at Eastern Virginia Medical School. “When the flora is altered, usually as a result of antibiotic treatment for an unrelated illness, the C. diff flourishes and produces two very potent toxins, Toxins A and B, which produce severe, potentially-fatal diarrhea.”

The survey also revealed that the rate is 6.5 to 20 times greater than previous incidence estimates.

“The National Prevalence Study of Clostridium difficile in U.S. Healthcare Facilities” study, which surveyed 648 acute care facilities and other centers, estimates that there are at least 7,178 inpatients on any given day in American healthcare institutions suffering from C. diff with an associated cost of between $17.6 million and $51.5 million.

“Almost one in four CDAD patients will experience a recurrence of symptoms after a round of antibiotic therapy alone,” Raymond said. “When a relapse occurs, use of [the probiotic] Florastor during the second antibiotic course can help protect against future relapses because it colonizes the gut with S. boulardii, which can help fight recurrent C. diff.”

A recent meta-analysis of 31 studies compiled and published in the American Journal of Gastroenterology concluded that S. boulardii is the only probiotic that is effective in fighting recurrent C. diff-associated disease. Additionally, an article in the March 2006 issue of Gastroenterology and Hepatology showed that use of S. boulardii provided an almost 50 percent decrease in subsequent recurrence among patients who suffered recurrent CDAD symptoms.

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FDA raises questions about efficacy of pain medication tamper-proofing

BY Alaric DeArment

NEW YORK Questions have arisen as to whether a pill by Pain Therapeutics and King Pharmaceuticals is resistant to tampering.

A memo by the Food and Drug Administration Monday concerns the drug Remoxy, a formulation of oxycodone that uses liquid capsule drug-delivery technology designed to prevent misuse of the drug. Some people have abused oxycodone tablets by crushing them, dissolving it in water and then injecting it for its opiate-like effects.

The FDA’s memo said that Pain Therapeutics did not sufficiently conduct long-term tests of Remoxy to determine whether the oxycodone could be extracted and diverted, though Pain Therapeutics disputes that claim.

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Titan releases earnings report for Q3 2008

BY Alaric DeArment

SOUTH SAN FRANCISCO, Calif. Titan Pharmaceuticals has released financial results for third quarter 2008.

Total operating costs for the quarter, which ended Sept. 30, were $6 million, compared with $4.6 million for third quarter 2007, the company said. Net loss for the quarter was $5.9 million, compared to $4.3 million last year; losses in both cases totaled 10 cents a share. The increase in operating costs resulted mostly from an increase in research and development funding related to development of the opiate addiction treatment Probuphine (buprenorphine) and a slight increase in general and administrative costs.

“We have continued to streamline our expenses and focus our resources on the phase 3 clinical development of Probuphine,” Titan president and chief executive Marc Rubin said. “During the third quarter, we have engaged in discussions with several potential partners both in the U.S. and Europe, and we are continuing these efforts as we evaluate strategic alternatives for the company.”

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