Iroko Pharmaceuticals, LLC today announced that the Phase 3 study evaluating the company's investigational, lower dose submicron indomethacin in post-surgical acute pain met its primary endpoint of demonstrating significant pain relief compared with placebo. Full results from the study will be presented at a future medical meeting.
"Physicians continue to face the challenge of balancing efficacy with safety when treating patients with pain," stated Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. "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."
In the Phase 3, multi-center study of lower dose submicron indomethacin, 462 patients were randomized to receive submicron indomethacin (40mg twice or three times daily, or 20mg three times daily), celecoxib (400mg loading dose; 200mg twice daily,) or placebo. All doses of submicron indomethacin met the primary objective of demonstrating significant improvement in pain relief as measured by the combined differences in pain intensity evaluated at intervals over 48 hours using a visual analog scale (VASSPID-48) in patients with acute pain.
"Our multiple lower dose submicron NSAID programs are aimed at applying scientific innovation to the management of pain, to offer patients and physicians much needed options," said John Vavricka, President and CEO of Iroko Pharmaceuticals. "Data from this study, together with positive results announced earlier this year from our Phase 3 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."
"These results add to the body of data from our pipeline and represent an important milestone toward our vision of developing a unique pharmaceutical portfolio focused on pain management," said Osagie Imasogie, Iroko Chairman and Senior Managing Partner of Phoenix IP Ventures.