New osteoarthritis drug expands options for low-dose NSAIDs
FDA approved meloxicam (Vivlodex, Iroko Pharmaceuticals, LLC) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain in 5-mg and 10-mg doses administered once daily.
Young, MDFDA approved meloxicam (Vivlodex,
Osteoarthritis, the most common form of arthritis, affects approximately 27 million Americans, according to the US Department of Health and Human Services.
Vivlodex is the first FDA-approved low-dose SoluMatrix meloxicam containing meloxicam drug particles that are 10 times smaller than their original size. The reduced particle size provides an increased surface area, leading to faster dissolution and absorption.
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“Vivlodex was designed to align with FDA recommendations to use the lowest effective dose [of NSAIDs] in view of the dose-related risks of serious cardiovascular and gastrointestinal events,” according to Clarence Young, MD, chief medical officer of Iroko Pharmaceuticals.
“The use of NSAIDs is associated with serious cardiovascular, gastrointestinal and renal adverse events and the risk of these events has been shown to be dose-related,” Dr Young said. “As a result, FDA recommends that all NSAIDs be used at the lowest effective dosage for the shortest duration consistent with individual treatment goals.”
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