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The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals' 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.
“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 III 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 29th Annual Meeting of the American Academy of Pain Medicine (AAPM) in Florida.
The risk of adverse events, including upper gastrointestinal ulcers, gastrointestinal bleeds, and cardiovascular events associated with currently marketed NSAIDs is higher among patients receiving higher doses of NSAIDs. Iroko is at the forefront of the development of lower dose submicron NSAIDs – new drug products based on existing NSAIDs – that are designed to potentially provide effective pain relief at lower doses than existing commercially available oral drug products. These lower dose submicron NSAIDs are being developed by Iroko, using iCeutica Pty Ltd’s proprietary SoluMatrix technology, licensed to Iroko for exclusive use in NSAIDs. The SoluMatrix technology alters the pharmacokinetic absorption properties of NSAIDs by reducing drug particles to finer particles that are at least 10 times smaller than standard oral NSAID formulations, thereby enhancing drug dissolution and promoting absorption.
Iroko is a global specialty pharmaceutical company, dedicated to scientific advancements in analgesia. The company acquires, develops and globally commercializes currently marketed products.
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