PHILADELPHIA — Iroko Pharmaceuticals on Friday received Food and Drug Administration approval for its low-dose NSAID Vivlodex (meloxicam). The drug, which is indicated to manage pain associated with osteoarthritis, uses SoluMatrix’s Fine Particle Technology to meet FDA guidelines that an NSAID contain the smallest possible dose over the shortest amount of time to prevent adverse drug events.
“Vivlodex is Iroko’s third FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology,” Iroko’s CEO and board chairman Osagie Imasogie said. “Now that we have added a low dose meloxicam product to our growing franchise, we can extend our reach to offer an additional formulation of one of the most commonly used NSAIDs for those affected by osteoarthritis pain, a common cause of disability and the most common type of arthritis.”
Vivlodex will be available in 5- and 10-mg dosage strengths.