Iroko Pharmaceuticals has reported positive results from its Phase III studies of lower dose submicron indomethacin in patients with post-surgical pain, and lower dose submicron diclofenac in patients with osteoarthritis pain.

Both the studies of its investigational submicron non-steroidal anti-inflammatory drug (NSAID) pipeline met their primary endpoints of providing considerable pain relief compared with placebo.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

“Both the studies of its investigational submicron non-steroidal anti-inflammatory drug (NSAID) pipeline met their primary endpoints of providing considerable pain relief compared with placebo.”

Weill Medical College of Cornell University medicine and public health professor Alan Gibofsky said existing NSAIDs formulations are associated with significant risk for adverse events, which increase with dose and duration of use.

“Lower dose options that reduce the amount of medication in a patient’s bloodstream, while preserving efficacy and onset of action, may be a valuable addition for physicians,” Gibofsky said.

In a Phase III multi-centre submicron indomethacin study, lower dose indomethacin provided significant improvement in pain relief in patients with post-surgical acute pain, as measured by a visual analog scale (VASSPID-48).

In the submicron diclofenac Phase III study, lower dose submicron diclofenac provided significant reduction in pain in osteoarthritis patients compared with placebo, as measured by the mean change from baseline in the Western Ontario and McMaster Universities Arthritis Index pain subscale at week 12.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Iroko Pharmaceuticals president and CEO John Vavricka said; “Our multiple Phase III data presentations reinforce the potential of submicron NSAIDs to provide effective pain relief at lower doses in a variety of pain models.”