General Information

Vivlodex (meloxicam) is a non-steroidal anti-inflammatory.

Vivlodex is specifically indicated for the management of osteoarthritis pain.

Mechanism of Action

Vivlodex (meloxicam) is a non-steroidal anti-inflammatory. It has analgesic, anti-inflammatory and antipyretic properties. The mechanism of action of Vivlodex, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Side Effects

Adverse effects associated with the use of Vivlodex may include, but are not limited to, the following:

• Diarrhea
• Nausea
• Abdominal discomfort

Vivlodex comes with a boxed warning of the potential for nonsteroidal anti-inflammatory drugs (NSAIDs) to cause an increased risk of serious cardiovascular and gastrointestinal events.

Dosing/Administration

Vivlodex is supplied as a capsule for oral administration. The recommended starting dose is 5 mg orally once daily. The dose may be increased to 10 mg in patients who require additional analgesia. Use the lowest effective dose for shortest duration consistent with individual patient treatment goals.

Clinical Trial Results

FDA Approval

The FDA approval of Vivlodex was supported by data from a Phase 3, multicenter, double-blind, placebo-controlled study of 402 patients, ages 40 and older, with pain due to osteoarthritis of the knee or hip, who were randomized to receive treatment with once-daily Vivlodex 5 mg, Vivlodex 10 mg or placebo over a period of 12 weeks. The Vivlodex doses studied achieved efficacy at 33 percent lower doses than currently available meloxicam products.