Last week, the FDA approved a new nonsteroidal anti-inflammatory drug (NSAID) for the management of osteoarthritis pain. Iroko Pharmaceuticals’ 5 and 10 mg meloxicam (Vivlodex™) capsules are 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. The FDA approval follows on data from a phase 3 study of 402 patients with osteoarthritis pain in the hip or knee. The study found that Vivlodex achieved efficacy at 33% lower doses than currently available meloxicam products.
Related to the development, PAINWeek faculty member Jeffrey Fudin, BS, PharmD, DAAPM, FCCP, FASHP, has observed “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.” In a press release, Iroko chief medical officer Clarence Young, MD, added “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.” Read a news story about the FDA action, with link to additional commentary from Dr. Fudin, here. Read the manufacturer’s press release on the approval of Vivlodex here.