FDA Approves Iroko’s Osteoarthrosis Drug

The FDA has approved Iroko Pharmaceutical’s low-dose nonsteroidal anti-inflammatory drug Vivlodex for the management of osteoarthrosis pain.

Vivlodex is the first FDA-approved low- dose, rapid-dissolution meloxicam — the second most commonly prescribed NSAID in the U.S. The drug was developed using proprietary technology that makes the meloxicam particles 10 times smaller than their original size, allowing them to dissolve more quickly.

Iroko developed the drug to align with recent FDA recommendations that NSAIDs be used at the lowest effective dose for the shortest possible time. In July, the agency required labeling for NSAIDs include warnings of serious cardiovascular and gastrointestinal adverse events associated with higher doses and long-term use.

The drug is Iroko’s second low-dose NSAID for osteoarthritis developed using the proprietary technology. The other is Zorfvolex (diclofenac).