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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, 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.
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.
“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.”
NEXT: FDA approval supported by phase 3 data
In July 2015, FDA announced that it is strengthening the warning in existing labels to indicate that non-aspirin NSAIDs increase the chance of heart attack or stroke. Based on FDA’s comprehensive review of new safety information, the agency is requiring updates to the drug labels of all non-aspirin prescription and over-the-counter NSAIDs.
To align with FDA’s recommendations, Dr Young says that the manufacturer has used SoluMatrix Fine Particle Technology to re-engineer meloxicam, one of the most commonly used NSAIDs.
Iroko now has 2 other FDA-approved low dose NSAIDs created using this technology, including indomethacin (Tivorbex) and diclofenac (Zorvolex) capsules.
FDA approval of the drug was supported by data from a phase 3, multicenter, double-blind, placebo-controlled study of 402 patients, aged 40 and older, with pain due to osteoarthritis of the knee or hip. Patients in this study were randomly assigned 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 a 33% (one-third) lower doses than currently available meloxicam products.
In the phase 3 pivotal trial, the most frequently reported adverse events (occurring in ≥2% of patients) in patients in the combined Vivlodex treatment group were diarrhea, nausea and abdominal discomfort.
“Despite advances in understanding and treatment, pain remains a major public health challenge that exacts a significant personal and economic toll on Americans, accounting for an estimated 70 million physician visits every year,” according to Dr Young.
NSAIDs are among the most widely used medications for treating pain and inflammation, however the risk of serious cardiovascular, gastrointestinal and renal adverse events associated with NSAIDs is higher among patients receiving higher doses.â¨It is estimated that serious gastrointestinal complications related to NSAID use account for as many as 16,500 deaths and 103,000 hospitalizations per year in the United States, according to Dr Young.