PARSIPPANY, N.J., Dec. 1 Pacira Pharmaceuticals, Inc., announced today that its second Phase III placebo controlled study of EXPAREL(TM) (DepoBupivacaine) met its primary endpoint. The multicenter, randomized, double-blind, parallel group, placebo controlled study in hemorrhoidectomy showed a statistically significant reduction in area under the curve analysis (AUC) of the NRS pain scores in patients receiving EXPAREL(TM) compared to placebo through 72 hours (p<0.0001).
The study also demonstrated opioid sparing through multiple secondary endpoints:
EXPAREL(TM) was well tolerated, with the incidence of adverse events similar to placebo. GI side effects, commonly associated with opioid use, were reduced in the EXPAREL(TM) group compared to placebo. No serious adverse events were reported in patients receiving EXPAREL(TM).
The Phase III trial studied 189 patients to determine the safety and efficacy of a single administration of EXPAREL(TM) for prolonged post operative analgesia in patients undergoing hemorrhoidectomy.
In October 2009 the Company reported positive data from a placebo controlled Phase III study in patients undergoing bunionectomy.
"We are delighted to announce the positive results from our second Phase III placebo controlled clinical trial," commented Gary Patou, MD, Chief Medical Officer for Pacira. "In this latest study we were able to demonstrate the analgesic effect of EXPAREL(TM) at every interval up to 72 hours post operative in a soft tissue setting. The earlier positive Phase III study demonstrated an analgesic effect in an orthopedic setting. Both studies met their primary endpoints."
EXPAREL(TM), a proprietary product of Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained release formulation of bupivacaine HCl, a local anesthetic/analgesic widely used for treating post operative pain. EXPAREL(TM) is the latest product to benefit from Pacira proprietary sustained-release DepoFoam® technology. DepoFoam® technology is designed to address the limitations of widely used medications 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 post operative pain relief by infiltration, is in late Phase III clinical development for postsurgical pain. EXPAREL(TM) benefits from the proprietary DepoFoam® Technology owned by Pacira. Two other DepoFoam®-based products -- DepoDur® and DepoCyt/DepoCyte® -- 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(TM) clinical development and all pipeline materials. Additional information about Pacira is available at www.pacira.com.
-- The percentage of patients who were opioid free was statistically significantly higher (p<0.0008) in the EXPAREL(TM) group compared to the placebo group. -- Median time to 1st opioid rescue was 1 hour and 10 minutes in the placebo group, and 14 hours and 20 minutes in the EXPAREL(TM) group. This difference was statistically significant (p<0.0001). -- EXPAREL(TM) patients showed a statistically significantly reduced total opioid consumption through 72 hours compared to the placebo group (p=0.0006).
SOURCE Pacira Pharmaceuticals, Inc.