General Information

Canasa (mesalamine) is a rectal suppository that has been approved by the FDA for the treatment of active ulcerative proctitis. Ulcerative proctitis is a less severe form of ulcerative colitis - a disease that causes inflammation and ulcers in the top layers of the lining of the large intestine. Ulcerative proctitis differs from ulcerative colitis in terms of where the inflammation occurs. In ulcerative proctitis, inflammation is only present in the rectum, and the upper limit of inflammation is visible via sigmoidoscopy. In ulcerative colitis, inflammation usually occurs in the rectum and lower part of the colon, but it may affect the entire colon.

In August 1999, the FDA requested that Axcan sell Canasa in the United States under a temporary, emergency measure due to the lack of any other source of supply. Subsequently, Axcan performed preclinical and clinical studies and filed an NDA on April 28, 2000. In conjunction with the approval, Axcan will perform a clinical study in children ages 12-18 years with active or quiescent (inactive) disease, since this condition may also be diagnosed at a young age.

Side Effects

Side effects that may occur with the use of drugs containing mesalamine include (but are not limited to) the following:

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• Allergic reaction
• Nausea or vomiting
• Abdominal cramping
• Headache
• Dizziness
• Chills

Mechanism of Action

The manner in which mesalamine provides a therapeutic effect for ulcerative proctitis is currently unknown.

Additional Information

For additional information on Canasa, please visit Axcan's web site.