FDA Approves Nano-Formulated Meloxicam for Osteoarthritis Pain
The FDA has approved Iroko Pharmaceuticals' 5 and 10 mg meloxicam capsules (Vivlodex) for the once-daily management of osteoarthritis pain.
The FDA today approved Iroko Pharmaceuticals’ 5 and 10 mg meloxicam (Vivlodex) capsules for the once-daily management of osteoarthritis pain.
Vivlodex, a nonsteroidal anti-inflammatory drug (NSAID), is the first FDA-approved low-dose meloxicam developed using the manufacturer’s SoluMatrix Fine Particle Technology, in which the meloxicam particles are approximately 10 times smaller than their original size. This reduction provides the drug with an increased surface area, allowing it to be more quickly dissolved and absorbed.
“Nanotechnology has been used in various drug delivery systems to manipulate the pharmacokinetic profile of certain medications and optimize pharmacodynamics at lower doses,” Jeffrey Fudin, BS, PharmD, DAAPM, FCCP, FASHP, and Mena Raouf previously wrote. “Low-dose micronized NSAIDs have been developed using nanotechnology to increase drug surface area and enhance absorption, thereby achieving comparable efficacy to conventional formulations at minimal doses with reduced adverse event risks.”
The FDA based its approval on data from a phase 3 study in which the safety and efficacy of Vivlodex was examined in 402 patients who were experiencing pain due to osteoarthritis of the knee or hip. The researchers found that the drug achieved efficacy at 33% lower doses than currently available meloxicam products.
“Research has shown that the use of NSAIDs is likely to increase as the US population continues to age and experience painful conditions that are more common among older adults,” said Iroko chief medical officer Clarence Young, MD, in a press release. “Patients with osteoarthritis are often treated with NSAIDs for extended periods to manage their pain. For that reason, this approval is important as we continue to expand the number of low dose NSAID options for patients.”
The approval is timely, because in July 2015, the FDA strengthened the existing label warnings for NSAIDs, cautioning that the drug class can increase the risk of heart attack and stroke. The agency recommended that NSAIDs be used at the lowest effective dose for the shortest duration to potentially minimize these risks.