Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Hernia Repair Presented at the Postgraduate Assembly in Anesthesio...(alatingstudy evaluated the efficacy safe...),Health

Date:12/14/2008

alating study evaluated the efficacy, safety, and pharmacokinetics of EXPAREL compared to bupivacaine HCL in 76 adult male patients (age ranges 48 to 63) in 10 hospitals in the UK and Australia. Subjects were randomized into one of four cohorts and intraoperatively administered either 175mg, 225mg, 300mg or 325mg of EXPAREL or 100mg bupivacaine HCL around the surgical wound by infiltration immediately before closure.

-- There was a statistically significant reduction in pain intensity with activity across all EXPAREL doses during the first 8 to 24 hours after surgery compared to bupivacaine HCL (P<0.05). Each patient's pain intensity score after surgery ranged from 21 - 31 across all EXPAREL groups compared to 45 - 48 for bupivacaine as measured by the Visual Analogue Scale (VAS) at 8, 12 and 24 hours.

-- The research also showed a trend toward lower opioid use in all EXPAREL groups compared to active control.

-- More patients in the EXPAREL groups completely avoided opioids 71% to 83% across doses, versus 50% for the bupivacaine groups.

-- Pharmacokinetic findings showed that a single intraoperative infiltration of EXPAREL resulted in dose-proportional sustained (72 hours) plasma concentrations of bupivacaine (>100mg/mL).

Safety assessments reported in the poster found EXPAREL to be safe and well-tolerated. Wound healing was normal in all EXPAREL subjects with no significant differences between cohorts. Adverse events were generally mild to moderate with no significant differences between cohorts and no serious adverse events were attributed to the study drug.

Inguinal hernia repair is one of the most common operations in routine surgical practice. In the U.S., more than 600,000 procedures are performed annually with a majority performed on an out-patient basis, according to the National Center for Health Statistics.

The Potential of EXPAR
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SOURCE Pacira Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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