New treatment for Crohn's disease

FDA Consumer, Nov-Dec, 2001

The FDA has approved Entocort EC (budesonide) capsules for the treatment of mild to moderate Crohn's disease involving certain sections of the small and large intestines.

Crohn's disease is a chronic inflammatory bowel disease characterized by diarrhea, abdominal pain or cramping, fever, fatigue, loss of appetite, and weight loss. Entocort EC, an orally administered steroid, is released in the intestine, where it works to decrease inflammation.

Because most of Entocort EC is not absorbed into the body, people taking the treatment may experience fewer of the typical side effects associated with other steroids used to treat Crohn's disease such as prednisone and prednisolone tablets.

Entocort EC was studied in 651 patients with active Crohn's disease. Those treated with Entocort EC experienced significant improvement in their symptoms. The most common adverse events were headache, respiratory infection, and nausea. In addition, fewer people receiving Entocort EC experienced facial swelling and acne than those receiving prednisolone.

AstraZeneca LP of Wilmington, Del., manufactures Entocort EC.