Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Number of Patients With Perceptible Pain Relief on Day 1

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

Time frame: 8 hours post single dose

Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1

Time frame: 8 hours post single dose

Number of Patients With Meaningful Pain Relief on Day 1

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

Time frame: 8 hours post single dose

Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1

Time frame: 8 hours post single dose

Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug

Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.

Time frame: 8 hourse post single dose

Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug