PIII‐6

BACKGROUND The purpose of this analysis was to assess the relation between pain relief evaluation by subjects with acute pain following analgesic medication and the time elapsed to obtain pain relief. METHODS We performed a raw data analysis of 304 subjects included in a clinical trial submitted to the Food and Drug Administration using the third molar post extraction dental pain model. The study was a randomized, double‐blind, controlled trial. Eligible subjects were otherwise healthy men or nonpregnant women older than 16 years of age. The primary end point analyzed was the time to meaningful pain relief. The study design has been approved by the responsible IRB. RESULTS The study population included 187 females and 117 males. Our breakout has been between responders and nonresponders. Pain relief responders rated the drug mainly as excellent or good. Median time for drug responders to achieve meaningful pain relief showed that 110 subjects who reported an excellent response, reported it 28 minutes following medication, 85 subjects who reported a good response, reported it 48 minutes following medication, and 19 subjects who reported a fair response, did it 60 minutes following medication. Nonresponders mainly rated the drug they took as poor or fair anytime following medication. CONCLUSIONS Faster median response to achieve meaningful pain relief has related to the drug efficacy evaluation. It clearly demonstrates that more rapid pain relief is associated with a better rating of the drug. Clinical Pharmacology & Therapeutics (2005) 79 , P59–P59; doi: 10.1016/j.clpt.2005.12.214