Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug.
The proposed indication of the potent anti-inflammatory and analgesic drug is for the treatment of mild to moderate acute pain in adults.
Indomethacin NDA included data from two Phase III multicenter, randomized, double-blind, controlled trials, which included 835 patients with acute pain following surgery and designed to compare the analgesic efficacy of the active treatment groups with placebo.
Iroko chairman Osagie Imasogie said, "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."
In February 2013, FDA accepted the NDA filing for Iroko's lower dose submicron diclofenac for the treatment of mild to moderate acute pain in adults.
