FDA approves Iroko's Zorvolex for treatment of osteoarthritis pain
- Zorvolex was approved in October 2013 for the treatment of mild-to-moderate acute pain in adults.It is the first FDA-approved, low-dose NSAID developed using Iroko’s SoluMatrix Fine Particle Technology
- The fine particle technology component of Zorvolex centers on delivering diclofenac in the form of submicron particles that are roughly 20 times smaller than their original size.
- Results from a 12-week, placebo-controlled, double-blind, parallel-group study involving 305 patients between the ages of 41 and 90 were used to support the submission of Zorvolex for this indication.
Iroko’s new technology bodes well for pain-wracked patients. As Pharmaceutical Business Review explains, the decreased particle size of Zorvolex results in increased surface area. That means that the drug dissolves faster and provides pain relief at a faster rate than if the particles had been administered in their original size.
Clarence Young, chief medical officer for Iroko, said, “Iroko has already made steady strides to help fill the need for low-dose NSAID options in patients with acute pain and we are continuing to expand our portfolio to also address chronic pain indications.”
- Pharmaceutical Business Review FDA approves Iroko's Zorvolex for osteoarthritis pain management