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November 9, 2001
The U.S. Food and Drug Administration (FDA) has approved the use of CELEBREX® (celecoxib capsules) for the effective management of acute pain and primary dysmenorrhea (menstrual pain) in adults. Importantly, this new indication provides patients the benefit of being able to take an additional dose if needed for individualized relief of acute pain.
"With this approval CELEBREX has the broadest range of approved indications of any COX-2 specific inhibitor," said Carrie Cox, President of Pharmacia’s Global Prescription Business. "We are pleased with the Agency's action because it reaffirms the efficacy and safety profile of CELEBREX and also allows CELEBREX to effectively compete in the large acute pain market, " she added.
The FDA approval followed a review of data from the clinical studies of more than 1,700 patients with post oral-surgery pain, musculo-skeletal pain, post-orthopaedic surgery pain or primary dysmenorrhea where patients rated their pain as moderate to severe.
“This approval provides doctors with an effective and well-tolerated addition to the management of acute pain,” said Evan Ekman, M.D., Director of Southern Orthopaedic Sports Medicine in Columbia, S.C. “CELEBREX provides a proven pain relief treatment option for the millions of patients with acute pain and arthritis,” Dr. Ekman said.
CELEBREX is the only COX-2 specific inhibitor approved to date for the relief of pain and inflammation of osteoarthritis (OA) and adult rheumatoid arthritis (RA). In addition, it is also approved to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) – a rare and devastating genetic disease that may result in colorectal cancer – as an adjunct to usual care.
CELEBREX is now approved for the relief of the signs and symptoms of OA and
adult RA in 83 countries worldwide and for the management of pain in Latin America, South Africa and the United States.
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