Presented at the 2013 AAPM Annual Meeting « Back

Lower-Dose, Indomethacin Submicron Particle Capsules Demonstrate Effective Analgesia in a Phase 3 Post-Surgical Moderate to Severe Pain Model Study

Roy Altman, MD, journals@royaltman.com¹, Stephen Daniels,DO², Clarence L. Young, MD³, (1) UCLA, David Geffen School of Medicine, Los Angeles, California, (2) Premier Research Group, Austin, Texas, (3) Iroko Pharmaceuticals, Philadelphia, Pennsylvania

Introduction: Early management of acute pain is important for controlling pain severity and duration. NSAIDs are commonly used to treat acute pain but have the potential for serious dose-related adverse events (AEs). Investigational submicron particle NSAIDs using proprietary SoluMatrix™ technology could provide effective pain relief at lower doses than currently available oral NSAIDs. This Phase 3 study evaluated the analgesic efficacy and safety of lower-dose, indomethacin submicron particle capsules and celecoxib versus placebo in a moderate to severe post-surgical pain model. Methods: This multi-center, double-blind, study randomized 462 adults following bunionectomy surgery under regional anesthesia. Patients experiencing a pain intensity rating ≥40mm on visual analog scale (VAS) received indomethacin submicron particle capsules (20 or 40mg TID or 40mg BID), celecoxib (400mg loading dose; 200mg BID), or placebo. The primary endpoint was the VAS summed pain intensity differences (VAS SPID) over 48h. Results: The 3 indomethacin submicron particle capsules treatment groups met the primary endpoint (P≤0.046), in contrast to celecoxib (P=0.103). Some pain control (mean VASPID) was apparent for indomethacin submicron particle 40mg TID (2.9) and 40mg BID (2.6) at 30min. Indomethacin submicron particle 40mg TID (P=0.013) and 40mg BID (P=0.014) provided better pain control 0-4h following enrollment (VAS SPID-4) versus placebo. Treatment-emergent AEs were similar across treatment groups and included nausea, post-procedural edema, dizziness, and headache. Conclusions: Lower-dose, indomethacin submicron particle capsules provided better pain control over 48h compared with placebo, and were generally well-tolerated. Indomethacin submicron particle capsules are a potentially promising therapeutic option for patients with acute pain. References: 1) Carr DB, Goudas LC. Acute pain. Lancet 1999;353:2051-8 2) Schjerning Olsen A-M, Fosbøl EL, Lindhardsen J, et al. Duration of Treatment With Nonsteroidal Anti-Inflammatory Drugs and Impact on Risk of Death and Recurrent Myocardial Infarction in Patients With Prior Myocardial Infarction / Clinical Perspective. Ci

Funding: Supported by Iroko Pharmaceuticals, LLC, Philadelphia, PA