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Dificid gets endorsement of FDA panel.

WASHINGTON -- An antibiotic developed by a San Diego drug firm has received the backing of a Food and Drug Administration panel as a treatment for diarrhea caused by bacterial infections.

The panel of outside experts unanimously agreed that fidaxomicin, marketed under the Dificid name by Optimer Pharmaceuticals Inc., is safe and effective in combating symptoms associated with Clostridium difficile, also known as c-diff, a bacterial infection that is often acquired in hospitals and nursing homes. The panel's 13-0 vote endorsed the FDA's preliminary findings and increases the chances that the agency will approve fidaxomicin. While the FDA is not required to follow the recommendations of its advisory panels, it usually does.

Optimer said it expects the agency to make a decision by May 30.

The advisory panel split, 6-6, with one abstention, on whether fidaxomicin was effective in reducing recurrence of c-diff infection-related diarrhea. Optimer executives say the advisory panel's split vote on the issue of recurrence reflected uncertainty over the wording of the question and not doubt about fidaxomicin's superiority in preventing the recurrence of diarrhea. Panel members said fidaxomicin's medical value may turn on its effectiveness in prevention of recurrences.

Among the research that the panel considered was a study showing that patients treated with fidaxomicin suffered recurrences in 15% of cases, compared to 25% for those taking the antibiotic vancomycin, the only other FDA-approved treatment for c-diff.

While the Centers for Disease Control and Prevention does not track c-diff specifically, researchers at the Society for Healthcare Epidemiology of America say it is the most commonly recognized cause of infectious diarrhea in health care settings.

"C-diff definitely is on the increase," Richard Dwyer, a gastroenterologist at Hollywood Presbyterian Medical Center in Los Angeles recently told the Los Angeles Times. He said the increase may be linked to overuse of antibiotics, which can kill beneficial bacteria and cause pathogens to develop resistance.

Meanwhile, Optimer and Cubist Pharmaceuticals Inc. have signed an exclusive two-year copromotion pact to market Dificid in the United States. Under the terms of the agreement, Optimer and Cubist will copromote the drug and will jointly provide medical affairs support for the product.

"Cubist has a proven track record and well-established relations with all stakeholders involved in the antibiotics space," Optimer president and chief executive officer Pedro Lichtinger said.

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Title Annotation:RX/Branded Drugs
Publication:Chain Drug Review
Date:Apr 25, 2011
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