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FDA Approves Vivlodex (meloxicam)

October 23, 2015
The new formulation contains microparticles of meloxicam that reduce the dose of NSAID needed for the treatment of osteoarthritis.

The US Food and Drug Administration has announced the approval of Vivlodex (meloxicam) capsules for the management of osteoarthritis pain. Vivlodex, a nonsteroidal anti-inflammatory drug (NSAID), will be available in 5 mg and 10 mg doses administered once daily, according to a press release from Iroko Pharmaceuticals, LLC.1

Vivlodex was developed using SoluMatrix Fine Particle Technology, which contains submicron particles of meloxicam that are approximately 10 times smaller than their original size. “The reduction in particle size provides an increased surface area, leading to faster dissolution.2 This allows clinicians to prescribe the lowest effective dose of NSAIDs for the shortest possible duration and marks an important milestone for the 27 million Americans who live with osteoarthritis,” noted the company.

Iroko developed the microparticle meloxicam to align with the FDA’s safety recommendations. In July 2015, the FDA strengthened the existing warning labels for non-aspirin NSAIDs.3 The serious cardiovascular and gastrointestinal adverse events associated with NSAIDs are dose-related and risk may occur early in treatment and may increase with duration of use.

“Meloxicam is the second most commonly prescribed NSAID in the US. The approval of Vivlodex is a welcome option that offers patients an effective, low dose NSAID, ” said Dr. Byron Cryer, Associate Dean at The University of Texas Southwestern Medical Center.4

“This is Iroko’s third FDA-approved low-dose NSAID developed using proprietary SoluMatrix Fine Particle Technology,” said Osagie Imasogie, Chief Executive Officer and Chairman of the Iroko Board. “Now that we have added a low-dose meloxicam product to our growing franchise, we can extend our reach to offer an additional formulation of one of the most commonly used NSAIDs for those affected by osteoarthritis pain, a common cause of disability and the most common type of arthritis.”4

Iroko has previously received approval to market Zorvolex (diclofenac) and Tivorbex (indomethacin), two new low-dose SoluMatrix NSAIDs for the treatment of acute and chronic pain.

How it Was Approved

The FDA approval 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 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 two treatment groups achieved efficacy at 33% lower doses than currently available meloxicam products. The New Drug Application (NDA) also included data from a 12-month open-label safety study that enrolled 600 patients, noted the press release.

Adverse Cardiovascular and GI Events

NSAIDs cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Vivlodex is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.  Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Last updated on: October 23, 2015
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FDA Strengthens Warning on NSAIDs