Mobic Receives FDA Approval for Treatment of rheumatoid arthritis
On August 9, the U.S. Food and Drug Administration (FDA) has approved the use of Mobic® (meloxicam) tablets for the management and treatment of rheumatoid arthritis (RA). Its use in osteoarthritis has been approved since June 2000.
The FDA approval resulted from data review from a placebo-controlled 12-week study of 1,184 patients with rheumatoid arthritis. Patients receiving Mobic® at the recommended starting doses of 7.5 and 15 mg were more likely to complete the study than those receiving placebo. The 22.5 mg dose yielded no significant benefit compared to the 15 mg dose.
Mobic® is approved in the U.S. for the treatment of osteoarthritis and rheumatoid arthritis at the same starting dose, 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. Higher doses of Mobic® (22.5 mg and greater) have been associated with an increased risk of serious GI events and should be avoided.