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Vivlodex Approval History

Vivlodex (meloxicam) is a low dose nonsteroidal anti-inflammatory drug (NSAID) indicated for the management of osteoarthritis pain.

FDA Approval: The approval of Vivlodex was supported by data from a Phase 3, multi-center, double-blind, placebo-controlled study of 402 patients, aged 40 and older, with pain due to osteoarthritis. The Vivlodex doses studied achieved efficacy at 33 percent lower doses than currently available meloxicam products. Vivlodex is a low-dose formulation utilizing submicron particles which provide an increased surface area and faster dissolution rates. It was was developed to align with current recommendations that NSAIDs be used at the lowest effective dose for the shortest possible duration.

Mechanism: Vivlodex (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID). It works by inhibiting prostaglandin synthesis.

Dosage and Administration: Vivlodex is a capsule taken once daily without regard to timing of meals. The recommended starting dose is 5 mg, but may be increased to 10 mg in patients who require additional analgesia.

Side Effects: The most common side effects associated with Vivlodex include diarrhea, nausea, and abdominal discomfort.

Additional Information: Vivlodex comes with a Boxed Warning advising patients and healthcare professionals of the potential for nonsteroidal anti-inflammatory drugs (NSAIDs) to cause an increased risk of serious cardiovascular and gastrointestinal events.

Development History and FDA Approval Process for Vivlodex

DateArticle
Oct 23, 2015Approval FDA Approves Vivlodex (meloxicam) for Osteoarthritis Pain

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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