Iroko Pharmaceuticals has announced positive results from its Phase III study of investigational, lower dose submicron indomethacin to treat post-surgical acute pain.
The study demonstrated significant pain relief compared with placebo, meeting the primary endpoint.
Iroko Pharmaceuticals chief medical officer Dr Clarence Young said; "These top line results lend further support to our novel approach to developing new NSAID formulations that may be able to do more with less, a concept that could represent a significant new development in the area of pain management."
A total of 462 patients were randomised to receive submicron indomethacin (40mg twice or three times daily, or 20mg three times daily), celecoxib (400mg loading dose, 200mg twice daily) or placebo in the multicentre study of lower dose submicron indomethacin.
According to the study data, all doses of submicron indomethacin met the primary objective of showing considerable improvement in pain relief, as measured by the combined differences in pain intensity assessed at intervals over 48 hours using a visual analog scale (VASSPID-48).
Iroko Pharmaceuticals president and CEO John Vavricka said the company’s multiple lower dose submicron NSAID programs are designed to apply scientific innovation to pain management, offering patients and physicians much needed options.
"Data from this study, together with positive results announced earlier this year from our Phase III study of lower dose submicron diclofenac in acute pain, add further momentum to Iroko’s goal of leading meaningful progress in this underserved therapeutic area," Vavricka said.