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.
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.
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."