You are here
Meloxicam Wins FDA Approval for Treatment of Rheumatoid Arthritis
"This FDA approval further underscores the efficacy and safety profile of MOBIC," said Paul Fonteyne, Executive Vice President, Head of Marketing and Sales Prescription Medicine. "Rheumatoid arthritis can be debilitating, and we hope this approval will enable many patients to find relief from the signs and symptoms associated with this disease."
The FDA approval follows a review of data from a placebo-controlled 12-week study of 1,184 patients with rheumatoid arthritis. Patients receiving MOBIC® (meloxicam) tablets at the recommended starting doses of 7.5 and 15 mg were more likely to complete the study than those receiving placebo. No incremental benefit was observed with the 22.5 mg dose 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 doses. The starting and maintenance dose is 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; therefore, the daily dose of MOBIC should not exceed 15 mg.
"Many of my osteoarthritis patients have found relief by using meloxicam (MOBIC)," said Dr. Peter T. Singleton (PM&R/Rheumatology), a Clinical Professor, Department of Orthopedic Surgery, Stanford University. "I have also seen the serious impact that rheumatoid arthritis can have on patients, and I'm pleased to be able to offer them an additional option for treating this painful disease."
About MOBIC® (meloxicam) tablets
MOBIC is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis, and has been available in the U.S. since June 2000.
MOBIC is contraindicated in patients who have experienced asthma, itching or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. As with all NSAIDs, serious GI toxicity such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine can occur at any time, without symptoms. As with other NSAIDs, MOBIC is not indicated for prevention of thromboembolic events and is not a substitute for aspirin or other drugs indicated for cardiovascular prophylaxis.
MOBIC was developed by Boehringer Ingelheim and is co-marketed with Abbott Laboratories. For more information, including full Prescribing Information, please visit https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Mobic/MobicTabs7-5-15mg.PDF.
Source: Boehringer Ingelheim Pharmaceuticals, Inc.