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Vioxx Receives FDA Approval

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Arthritis News – 1999

News Article
On May 21,1999, the U.S. Food and Drug Administration (FDA) approved Vioxx(rofexocib) for relief of the signs and symptoms of osteoarthritis (OA), management of acute pain in adults, and treatment of menstrual pain.

In clinical trials sponsored by Merck & Co., Vioxxat 12.5mg and 25 mg once daily was shown to be comparable to the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen at 800mg 3x daily and diclofenac at 50mg 3x daily for treatment of the signs and symptoms of osteoarthritis (OA). Results from two 6-month trials showed a significantly lower percentage of gastroduodenal ulcers in patients using 25mg or 50mg daily of Vioxxas compared to 2,400mg daily of ibuprofen.

Vioxxworks by inhibiting an enzyme called COX-2, which plays a role in OA, while sparing the COX-1 enzyme that helps maintain the normal stomach lining. NSAIDs in general inhibit both COX enzymes, so they treat pain and inflammation but may damage the stomach lining, potentially leading to ulcers in some patients. (more info on COX-2 inhibitors)

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