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FDA Recommends Approval for IBS Drug - Chronic Fatigue Syndrome & Fibromyalgia News

  [ 159 votes ]   [ Discuss This Article ]
By Tamara Schuit • • June 30, 2000

The FDA has recommended approval for Zelmac, the newest drug developed for the treatment of IBS.

Zelmac was developed to specifically target and act on serotonin receptors present in the GI tract that are believed to play a key roll in pain perception and GI motility. By targeting these receptors, Zelmac reduces abdominal pain and relieves constipation and bloating.

In studies involving 2,500 patients from over 15 countries, patients reported symptom improvement within a week’s time – some as early as the first day of treatment. In additional studies testing Zelmac against a placebo, patients reported a 50% improvement in abdominal discomfort, pain and irregular bowel habits.

Since the drug did not appear to be effective in men, the FDA will most likely only approve the drug for women with constipation.

Although the drug was found to be well tolerated by patients, reported side effects were diarrhea, which was reported early in the treatment and was resolved with continued therapy.

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