Presentation Outline ICHP Annual Meeting September 13-15

Cumulative Pain Score through 72 Hours
Cumulativ ve Pain Score
Gorfine et al. Dis Colon Rectum. 2011;54:1552-9.
P < 0.0001
No Opioid Rescue Medications vs Hours
Gorfine et al. Dis Colon Rectum. 2011;54:1552-9.
Liposomal bupivacaine 300 mg
Placebo
FDA Review
“Between 24 and 72 hours after study drug
administration, there was minimal to no
difference between EXPAREL and placebo
treatments on mean pain intensity; however,
there was an attendant decrease in opioid
consumption, the clinical benefit of which was
not demonstrated.”
Mean Total Amount of Opioids Over 72 Hr
Milligramss
(mg)
Gorfine et al. Dis Colon Rectum. 2011;54:1552-9.
Marketing
P < 0.006
“One dose of Exparel provides up to 72 hours of
postsurgical pain control with a decrease in
opioid consumption without the need for
catheters or pumps.”
Safety
• No primary safety outcome defined
• Identified opioid‐ related adverse effects
8/29/2012
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