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Vivlodex Approval History

FDA Approved: Yes (First approved October 22, 2015)
Brand name: Vivlodex
Generic name: meloxicam
Dosage form: Capsules
Company: Iroko Pharmaceuticals, LLC
Treatment for: Osteoarthritis

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

Further information

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