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| |  FDA Approved Celebrex In Adjunct Therapy For Familial Adenomatous Polyposis SKOKIE, IL -- December 23, 1999 -- The U.S. Food and Drug Administration (FDA) approved Celebrex(TM) (celecoxib capsules) as an oral adjunct to usual care (e.g., endoscopic surveillance and surgery) for patients with familial adenomatous polyposis (FAP) -- a rare and devastating hereditary disease that left untreated almost always leads to colorectal cancer. Celebrex, the only COX-2 specific inhibitor indicated for the treatment of both osteoarthritis and adult rheumatoid arthritis, is the first pharmacologic agent to be indicated to reduce the number of adenomatous colorectal polyps in patients with FAP.
"We are committed to fulfilling unmet medical needs for people who must live day to day with this severe and life-altering disease. The National Cancer Institute's sponsorship of the FAP clinical study underscores the importance of medical research into the needs of patient populations with devastating conditions," said Philip Needleman, Ph.D., co-president, Searle, and chief scientist, Monsanto, who discovered Celebrex. "We are just beginning to unlock the potential of Celebrex beyond arthritis." FAP is characterized by the development of hundreds to thousands of potentially pre-cancerous (adenomatous) polyps in the colon and rectum, which typically first appear in adolescence and early adulthood. Many of these polyps express high levels of COX-2 compared to normal adjacent tissue and may be precursor lesions for colorectal cancer. Left untreated, virtually all patients with FAP develop colorectal cancer by age 40-50. Until now, no drugs were approved for the care of patients with FAP. A six-month, 83-patient clinical trial, sponsored by the National Cancer Institute's Division of Cancer Prevention in collaboration with Searle, is the largest randomized, double-blind, placebo-controlled trial to date in FAP. The clinical study demonstrated that an oral dose of Celebrex 400 mg twice a day significantly reduced the number of adenomatous colorectal polyps by an average of 28 percent -- compared to a 5 percent reduction with placebo. The study was conducted at the University of Texas, MD Anderson Cancer Center in Houston, as well as at St. Mark's Hospital in London, the center for one of the world's premier registries of FAP patients. "This is the first real breakthrough in our ability to offer FAP patients a proven adjunctive therapy to usual care," said a lead investigator Gideon Steinbach, M.D., assistant professor of medicine, University of Texas, MD Anderson Cancer Center. "FAP is a life-threatening disease that urgently requires new treatment options in addition to what is now available. We believe that the FDA's approval of Celebrex represents an important step forward in bringing hope and state-of-the-art care to people with FAP," said Carolyn Aldige, president and founder, Cancer Research Foundation of America. Since the current trial did not include a cancer endpoint, the effect of Celebrex on the development of cancer has not yet been established. Searle and Pfizer will be conducting further studies to assess the clinical benefit of Celebrex in this setting. Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) should not use Celebrex. As with all NSAIDs, serious gastrointestinal (GI) tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to signs and symptoms of GI bleeding. In the FAP trial, common side effects were diarrhea and dyspepsia. Celebrex has not been shown to reduce the risk of GI cancer or the need for Searle and Pfizer are also conducting research, in collaboration with the National Cancer Institute, into the use of Celebrex in patients with sporadic adenomatous polyps (SAP) of the colon, Barrett's esophagus (considered a precursor to esophageal cancer), actinic keratosis (a precursor to skin cancer) and superficial bladder cancer. Celebrex is co-promoted by Searle and Pfizer Inc. Celebrex is available in 100 mg and 200 mg capsules.
Related Links: Searle and Pfizer Inc.
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