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news.Iroko Pharmaceuticals' Phase III studies of its investigational submicron non-steroidal anti-inflammatory drug (NSAID) pipeline met the primary endpoints of providing considerable pain relief in relation to placebo.
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Phase III studies investigated lower dose submicron indomethacin in patients with post surgical pain, and lower dose submicron diclofenac in patients with osteoarthritis pain.
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 added.
Phase 3 submicron indomethacin study demonstrated considerable improvement in pain relief in patients with post-surgical acute pain by lower dose indomethacin, as measured by a visual analog scale.
Submicron diclofenac Phase 3 study demonstrated significant reduction in pain in osteoarthritis patients compared with placebo by lower dose submicron diclofenac, as measured by the mean change from baseline in the Western Ontario and McMaster Universities Arthritis Index pain subscale at twelfth week.
Iroko Pharmaceuticals president and CEO John Vavricka said, "Our multiple Phase 3 data presentations reinforce the potential of submicron NSAIDs to provide effective pain relief at lower doses in a variety of pain models."