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Pharmacia and Pfizer Announce FDA Approval For New 400 mg Strength Celebrex® Capsule for Treatment of Familial Adenomatous Polyposis

Pharmacia Corporation and Pfizer Inc. September 6 announced that the U.S. Food and Drug Administration has approved a new 400-mg strength of Celebrex® (celecoxib capsules.) At a recommended dose of 400 mg twice per day, Celebrex is the first and only medication approved in the United States to reduce the number of colorectal polyps in patients with familial adenomatous polyposis (FAP) as a complement to traditional care (e.g., endoscopic surveillance, surgery).

 FAP is an inherited condition in which precancerous polyps grow in the colon. It is estimated that FAP affects an estimated 35,000 Americans. Left untreated, virtually all patients with FAP develop colon cancer by age 40-50.

Adenomatous polyps are a precursor to more than 95% of all colorectal cancer. “The use of Celebrex has been a valuable treatment addition for patients with FAP and has prompted additional research,” said Patrick Lynch, M.D., Associate Professor of Internal Medicine, M. D. Anderson Cancer Center, Houston, TX.

 “The new 400 mg strength capsule provides for more convenient dosing for these patients,” said Dr. Lynch. Celebrex, the number-one prescribed arthritis medication in the U.S., is the COX-2 specific inhibitor with the broadest range of approved indications. It is also available in 100 mg and 200 mg capsules for the treatment of osteoarthritis and adult rheumatoid

arthritis, as well as the management of acute pain and primary dysmenorrhea in adults.

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