New Sustained-Release Analgesic Significantly Reduces Postop Pain, Opioid Use, and Reduces Opioid Related Adverse Events Compared to Gold Standard Pain Medication
PARSIPPANY, N.J., Dec. 6 /PRNewswire/ -- A Phase II dose escalation study of a single intraoperative administration of EXPAREL(TM) (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
EXPAREL, a proprietary product from Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained-release formulation of bupivacaine HCL, 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
EXPAREL is a novel formulation of bupivacaine designed to provide effective, safe, prolonged (72 hours) postoperative pain relief in a single administration. Currently available local anesthetics typically have short (about 6 to 8 hours) duration of action resulting in limited pain relief in the first few days following surgery when pain is the most intense.
"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(R) 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.
Pacira Pharmaceuticals, Inc. is an acute care specialty pharmaceutical company founded in March, 2007 through the acquisition of the former SkyePharma PLC injectable business, for which an experienced management team was assembled to address the needs of the acute care market. The company's most advanced product, EXPAREL(TM) (DepoBupivacaine), a bupivacaine-based product intended to deliver postoperative pain relief by infiltration, is in late Phase III clinical development. Pacira will also study EXPAREL for nerve block, non-surgical pain such as long bone fracture and for intraarticular injection. EXPAREL benefits from the proprietary DepoFoam Technology owned by Pacira. Two other DepoFoam-based products -- DepoDur(R) and DepoCyt/DepoCyte(R) -- are marketed by partners in several global territories. The DepoFoam technology also forms the basis of multiple development projects providing Pacira an opportunity to expand its pipeline. Pacira owns two cGMP production facilities which produce the two approved products, EXPAREL clinical development and all pipeline materials.
Additional information about Pacira is available at www.pacira.com.
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.
Pacira Contact: Taunia Markvicka Vice President, Commercial Development 973 254 3565
|SOURCE Pacira Pharmaceuticals, Inc.|
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