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May 31, 2011

FDA Approves Dificid Tablets

Optimer Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhoea people aged 18 years or older. The approval of the antibacterial drug is based on results from

By cms admin

Optimer Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhoea people aged 18 years or older.

The approval of the antibacterial drug is based on results from two randomised, multicentre, double-blind trials which demonstrated its efficacy.

The studies were conducted in North America and enrolled 1,164 adults. They showed that 88% of patients who received the drug experienced a clinical response, compared to 86% of vancomycin-treated patients.

The adverse events seen included nausea, vomiting, abdominal pain, gastrointestinal haemorrhage, anaemia and neutropaenia.

Clostridium difficile-associated diarrhoea is a bacterial infection in the lining of the gut that can cause severe diarrhoea, inflammation of the colon and, in some cases, death.

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