Iroko Pharmaceuticals announced that the FDA has accepted for review the New Drug Application (NDA) for lower dose submicron indomethacin, a non-steroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults.
The NDA submission 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.
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.
For more information call (267) 546-3003 or visit www.iroko.com.