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FDA Approves Budesonide (Uceris) Rectal Foam for Patients With Distal Ulcerative Colitis
The FDA has granted final approval for budesonide (Uceris, Salix Pharmaceuticals) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge.
The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies, which are often ineffective because of insufficient distribution of active drug to the distal colon.
On September 15, 2014 the FDA tentatively approved budesonide rectal foam pending expiration of the 45-day waiting period described in the Federal Food, Drug, and Cosmetic Act. The waiting period has expired, and the FDA has granted the product final approval as of October 7, 2014.
UC is a chronic disease in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucous. The combination of inflammation and ulceration can cause abdominal discomfort and frequent emptying of the colon. Distal UC is characterized as either ulcerative proctitis (inflammation localized to the rectum) or ulcerative proctosigmoiditis (inflammation localized to the distal colon and rectum).
The Crohn’s and Colitis Foundation of America (CCFA) estimates that UC may affect as many as 700,000 Americans. While most people are diagnosed in their mid-30s, the disease can occur at any age and equally affects men and women. An estimated 46% of people with UC have distal disease.
About half of all patients with UC experience at least mild symptoms, including persistent diarrhea, accompanied by abdominal pain and blood in the stool and more urgent bowel movements. The CCFA also notes that people with UC often experience loss of appetite and may lose weight as a result. A feeling of low energy and fatigue is also common.
Rectal therapy is recommended for the induction of remission in patients with mild-to-moderate UC, and is recommended either alone or in combination with oral aminosalicyclic acid (ASA) for mild-to-moderate distal UC. However, currently available rectal therapies have limitations, including difficulty of administration and retention (enemas) and limited proximal spread (suppositories).
When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since budesonide is a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
Source: Salix Pharmaceuticals; October 8, 2014.