Iroko Pharmaceuticals announced that the Phase 3 study evaluating the company’s investigational, lower dose submicron indomethacin in post-surgical acute pain met its primary endpoint of demonstrating significant pain relief compared with placebo. Lower dose submicron indomethacin is being developed using proprietary SoluMatrix technology, which alters pharmacokinetic absorption properties of the NSAID indomethacin by reducing drug particles to finer particles that are at least 10 times smaller than standard formulations, thereby enhancing the drug dissolution and promoting absorption.
In the Phase 3, multi-center study, 462 patients were randomized to receive submicron indomethacin (40mg twice or three times daily, or 20mg three times daily), celecoxib (Celebrex; Pfizer) (400mg loading dose; 200mg twice daily) or placebo. All doses of submicron indomethacin met the primary objective of demonstrating significant improvement in pain relief as measured by the combined differences in pain intensity evaluated at intervals over 48 hours using a visual analog scale (VASSPID-48) in patients with acute pain.
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