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|Positive Phase II Study of Pacira's EXPAREL™ (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress|
New Sustained-Release Analgesic Significantly Reduces Postop Pain, Opioid Use, and Reduces Opioid Related Adverse Events Compared to Gold Standard Pain Medication
Parsippany, NJ, Dec. 6, 2008 - A Phase II dose escalation study of a single intraoperative administration of EXPAREL™ (DepoBupivacaine) in patients who underwent total knee arthroplasty, or TKA, showed that the novel, sustained-release analgesic effectively and safely controlled moderate-to-severe postoperative pain for over 72 hours, it was reported today in a poster at the Biennial World Congress of the International College of Surgeons in Vienna, Austria. Commenting on the results, Kenneth W. Bramlett, MD, Orthopedic Department, West Alabama Research in Birmingham, Alabama concluded EXPAREL significantly reduced postoperative pain, decreased the use of opioids (therefore lowering associated side effects), and allowed some patients to avoid the use of opioids altogether.
EXPAREL, a proprietary product from Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained-release formulation of bupivacaine, a local anesthetic widely used for treating postoperative pain.
Dr. Bramlett said, "EXPAREL effectively controlled moderate to severe pain for more than 72 hours, with better relief achieved with higher doses and a dose-dependent effect in both analgesia and reduction in opioid rescue." He pointed out the clinical importance of the study outcomes noting that EXPAREL efficacy was statistically significant against bupivacaine, the gold standard of local anesthetics, rather than simply placebo, concluding, "EXPAREL may provide safe and effective, prolonged pain relief and an opioid-sparing alternative to currently available local analgesics."
Findings as reported in the poster include:
The multi-center, double-blind, randomized Phase II study used a parallel-group, active-control format to evaluate the efficacy and safety of EXPAREL for prolonged postoperative analgesia. Either a single intraoperative administration of EXPAREL or active control was given via local infiltration to 103 adult patients undergoing TKA in 5 centers across the U.S. and Europe.
TKA is the leading orthopedic surgery in the U.S. with approximately 534,000 procedures performed annually according to the National Center for Health Statistics. It is expected that the number of total knee replacement procedures will increase as our population continues to age.
The Potential for EXPAREL
"The results of this study clearly demonstrate the potential of EXPAREL in fulfilling this unmet need," said Ronald Burch, M.D, PhD, Chief Medical Officer, Pacira. "EXPAREL represents an important advance in pain control that allows for extended delivery of bupivacaine, a well-characterized analgesic with a long-established efficacy and safety record. We look forward to sharing the results of multiple phase II and III clinical trials across a broad range of surgical procedures."
EXPAREL, currently in late Phase III clinical development, is being studied in several different types of surgical procedures where postoperative pain management is especially problematic. It is the latest product to benefit from Pacira Pharmaceutical's proprietary sustained-release DepoFoam® technology. DepoFoam technology is designed to address the limitations of widely known and used drugs by enhancing their dosing and/or administration profile. It achieves this by encapsulating the drug in multivesicular liposomal particles which then release the drug over a desired period of time without altering the drug molecule. DepoFoam is a proven technology that is already used in two commercially available products in the U.S. and Europe.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the preliminary results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.