Iroko announced that the Food and Drug Administration (FDA) has approved Vivlodex (meloxicam), a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.
The approval is based on data from a multicenter, double-blind, placebo-controlled Phase 3 study of 402 patients aged ≥40 with pain due to osteoarthritis of the knee or hip who received once-daily Vivlodex 5mg, 10 mg, or placebo over 12 weeks. The Vivlodex doses achieved efficacy at 33% lower doses than currently available meloxicam formulations. The New Drug Application (NDA) also included data from an open-label study of 600 patients over 12 months.
Vivlodex was developed using proprietary SoluMatrix Fine Particle Technology and contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area and leads to faster dissolution. It was developed to align with recommendations from the FDA and many professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration.
Vivlodex is supplied as 5mg and 10mg capsules in 30- and 90-count bottles.
For more information call (267) 546-3003 or visit Iroko.com.