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FDA Approval Means Americans with Osteoarthritis Have a New Option

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By News Release • www.ProHealth.com • April 14, 2000


SUMMARY: New to U.S., Mobic, an osteoarthritis treatment, has successfully treated millions of patients in more than 100 countries.

RIDGEFIELD, CT (April 14, 2000) -- The U.S. Food and Drug Administration has approved Mobic (meloxicam) tablets for marketing as a treatment for osteoarthritis. This decision gives patients in the United States an alternative that has been used in millions of patients worldwide for relieving the pain and stiffness associated with the disease. As the population ages, the need for effective pain relief from osteoarthritis -- which currently affects 80 percent of Americans over age 65 -- is expected to increase. Millions of people are still searching for an effective treatment they can tolerate. For these patients, today's clearance of Mobic tablets for marketing in the U.S. provides an important new option.

Often, arthritis patients try several medications and find they are not effective or cause side effects that make tolerating the medication difficult. Some patients keep searching, while others simply give up. Mobic tablets provide a new alternative for patients -- when beginning therapy or when other treatments are discontinued.

"Osteoarthritis can be a very debilitating condition, often diminishing the quality of daily life for people who suffer from it," says Dr. David Yocum, director of the University of Arizona Arthritis Center. "Many of these patients cannot be successfully treated with current options, and even the newest choices do not work for everyone. Mobic tablets provide patients with a new alternative when other treatments are discontinued, whether due to lack of efficacy or side effects."

The safety and efficacy of Mobic tablets were established through clinical trials involving more than 22,000 patients both here and abroad. The majority of patients taking Mobic tablets experienced relief from their osteoarthritis symptoms with a low incidence of gastrointestinal side effects.

In the United States, Mobic tablets are indicated as a once-daily medication for relief of the signs and symptoms of osteoarthritis. As the third new non-steroidal anti-inflammatory drug (NSAID) introduced to the market in the past two years, Mobic is being priced approximately 20 percent less than Celebrex®* and Vioxx®** for the starting and maintenance daily dose of 7.5 mg.

Osteoarthritis -- a painful, debilitating disease that causes cartilage acting as a cushion in joints to break down -- is the most common form of arthritis, affecting primarily older Americans. More than $65 billion is spent each year on medical expenses and lost wages related to arthritis. ,
Like any medication, Mobic tablets are not appropriate for everyone. Patients who have a known allergy to meloxicam, aspirin or other traditional NSAIDs should not use Mobic tablets, nor should women who are, or may be, pregnant. Although use of Mobic tablets shows good gastrointestinal tolerability, gastrointestinal ulcers can develop without warning symptoms. Patients and physicians should remain alert to the earliest signs and symptoms of gastrointestinal bleeding.

Sources: Pharmaceuticals, Inc. and Abbott Laboratories.



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