FDA accepts Iroko's submicron indomethacin NDA for treatment of acute pain in adults

Jul 16 2013

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to scientific advancements in analgesia, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lower dose submicron indomethacin, a non-steroidal anti-inflammatory drug (NSAID), for the proposed indication of treatment of mild to moderate acute pain in adults. This is the second NDA filing from Iroko's submicron NSAID pipeline to be accepted by FDA in 2013.

“Indomethacin is a drug with potent anti-inflammatory and analgesic properties. By developing a lower dose indomethacin, we aim to provide a new option for acute pain management. We look forward to working closely with FDA during the review process.”

"FDA's acceptance of our NDA filing for submicron indomethacin provides further momentum to our submicron NSAID strategy," said Osagie Imasogie, Chairman of Iroko Pharmaceuticals. "Indomethacin is a drug with potent anti-inflammatory and analgesic properties. By developing a lower dose indomethacin, we aim to provide a new option for acute pain management. We look forward to working closely with FDA during the review process."

Iroko is developing lower dose submicron NSAIDs, using proprietary SoluMatrix™ technology, designed to provide effective pain relief at lower doses than existing commercially-available NSAIDs. In February 2013, FDA accepted the NDA filing for lower dose submicron diclofenac for the treatment of mild to moderate acute pain in adults.

The NDA submission for lower dose submicron indomethacin included data from two Phase 3 multicenter, randomized, double-blind, controlled trials in 835 patients with acute pain following surgery. The trials were designed to compare the analgesic efficacy of the active treatment groups with placebo. Data from one of the studies were recently presented at the 29^th Annual Meeting of the American Academy of Pain Medicine (AAPM) in Fort Lauderdale, Florida in April 2013.