New Low Dose Osteoarthritis Pain NSAID Approved

The US Food and Drug Administration has approved meloxicam (Vivlodex/ Iroko Pharmaceuticals, LLC), a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of osteoarthritis pain.

The first FDA-approved low-dose formulation — 5mg and 10mg daily doses – was developed with the SoluMatrix Fine Particle Technology, which contains submicron particles of meloxicam. Approximately 10 times smaller than their original size, meloxicam reduced particle size is what leads to faster dissolution.

Researchers conducted a Phase 3 placebo-controlled study of 402 patients (40 years of age and older) who all suffered from osteoarthritis pain in the knee or hip. All patients were randomized to receive either once-daily Vivlodex 5mg or 10mg or placebo over a 12-week period.

The study results showed Vivlodex dosing was effective at 33% lower doses than currently available meloxicam products.

Vivlodex is contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

The most commonly reported adverse events associated with NSAIDs include bleeding, ulceration, and potential fatal perforation of the stomach/intestines.

Byron Cryer, MD, Associate Dean, University of Texas Southwestern Medical Center, said in a news release, “As recently as July 2015, the FDA announced they would strengthen the existing product label warnings for nonaspirin NSAIDS, further highlighting that NSAIDs should be used at the lowest effective dose for the shortest duration to potentially minimize the risk of adverse events.”