Presented at the 2012 AAPM Annual Meeting « Back

Acute Pain Relief by a Proprietary, Nanoformulated Lower Dose Oral Diclofenac

Allan Gibofsky, MD, gibofskya@hss.edu¹, Stephen Daniels, DO², Garen Manvelian, MD³, (1) Hospital for Special Surgery, New York, New York, (2) Premier Research Group, Austin, Texas, (3) Iroko Pharmaceuticals, Poway, California

Introduction: Diclofenac is commonly prescribed for acute pain relief. New NSAIDs are being developed to improve tolerability while maintaining efficacy. This study evaluated pain relief of an investigational, proprietary, nanoformulated, lower dose, oral diclofenac compared with placebo and celecoxib in a validated acute pain model. Materials and Methods: This was a Phase 2, multicenter, randomized, double-blind, single-dose, parallel-group, active- and placebo-controlled study. Subjects (N = 202) were 18–50 years old, had extraction of ≥2 third molars (≥1 of which was a fully or partially impacted mandibular third molar), and experienced moderate to severe pain intensity ≤6 hours post-surgery. Subjects assessed baseline pain intensity before receiving nanoformulated lower dose diclofenac 18 mg or 35 mg, celecoxib 400 mg, or placebo, and pain intensity and pain relief from 15 minutes through 12 hours. Results: The intent-to-treat population was analyzed. There was a significant difference in the mean VAS pain intensity difference (VASPID) for nanoformulated diclofenac 18 mg compared with placebo at 30 min (Table). For all time points between 45 minutes through 7 hours there was a significant difference in the mean VASPID for nanoformulated diclofenac 18 mg or 35 mg and celecoxib 400 mg compared with placebo. Tolerability data were comparable between treatment groups and placebo. Conclusion: Nanoformulated lower dose diclofenac demonstrated greater improvement in pain intensity compared with placebo. This Phase 2 clinical trial suggests that use of nanoformulated, lower dose diclofenac provides relief of acute pain.

Funding: Study was funded by Iroko Pharmaceuticals, LLC. Authors were not paid for this study.