New COX-2 Inhibitor, Mobicox (Meloxicam) Approved In Canada For Rheumatoid And Osteoarthritis
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New COX-2 Inhibitor, Mobicox (Meloxicam) Approved In Canada For Rheumatoid And Osteoarthritis

TORONTO, ON -- December 5, 2000 -- The latest drug in the family of COX-2 inhibitors, meloxicam, was approved for sale in Canada this month for the treatment of rheumatoid and osteoarthritis.

Known in Canada under the brand name Mobicox, the drug will now be a rival to Vioxx (Merck) and Celebrex (Pfizer-Searle), which have been available since 1999.

COX-2 inhibitors are increasingly important in the treatment of osteo- and rheumatoid arthritis because they spare the patient most of the gastrointestinal toxicity that is commonly seen in patients using traditional non-steroidal anti-inflammatories (NSAIDs) such as naproxen and ibuprofen.

According to the Arthritis Society of Canada, between 10-15 percent of chronic NSAID users will develop bleeding ulcers and 1900 people die each year because of bleeding associated with NSAID gastropathy.

None the less, meloxicam is actually the most widely studied COX-2 inhibitor in the world. Although there are no direct head-to-head comparisons with either of the other two contenders, a meta-analysis reported in the American Journal of Medicine found that among 20,000 subjects who had used the drug, the evidence clearly favored Meloxicam over serveral different NSAIDs on several different measurements.

- Gastro-intestinal adverse events reduced 36 percent
- Dyspepsia reduced by 27 percent
- Perforations, ulcerations or bleeding (PUB) reduced 48 percent
- Drug withdrawal due to any GI adverse event 41 percent lower than with traditional NSAIDs

Schoenfeld, Am J Med 1999; 107 (6A): 28S-54S.

In two specific studies, which compared meloxicam (7.5 mg/day) against two other widely used NSAIDs, piroxicam (20 mg), and diclofenac (SR 100 mg) among patients with osteoarthritis, there were statistically significantly lower risks of GI abnormalities in general and dyspepsia and abdominal pain in particular:

For example, compared with diclofenac, the differences were as follows:

-GI abnormalities 13 percent versus 18.8 percent
-dyspepsia 4.1 percent versus 5.7 percent
-abdominal pain 3.23 percent versus 5.6 percent

Hawkey et al, Br J Rheumatol 1998; 37: 937-945

And compared with piroxicam:

-GI abnormalisties 10.3 percent versus 15.3 percent
-dyspepsia 3.4 percent versus 5.6 percent
-abdominal pain 2.1 percent versus 3.5 percent

Dequeker et al, Br J Rheumatol 1998; 37; 946-951

The advent of the new COX-2 class of prescription treatments has meant "a significant advance in therapy that has helped to alleviate pain while reducing the risk of GI complications," but the cost of the drugs in Canada may be an issue, said Dr. Bert Tjeenk Willink, medical director, for Boehringer Ingelheim.

Indeed BI will be promoting Mobicox heavily on its price advantage - approxiately $0.78 per day (Cdn) as compared with $2-$2.50 per day with either of the currently existing COX-2 inhibitors.

It has been estimated by the Arthritis Society of Canada that four million Canadians suffer from osteo- and rheumatoid arthritis, and approximately 572,000 of them, or 2.3 percent of the population are disabled because of it. By the year 2031, it has been forecast that 3.3 percent of the Canadian population will be disabled because of arthritis.

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