Pacira's Phase III Study Of EXPAREL(TM) Meets Primary Pain Relief Endpoint

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 21 Oct 2009 - 2:00 PDT

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Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced that its Phase III study of its new analgesic EXPAREL(TM) (DepoBupivacaine) in patients undergoing a bunionectomy procedure met its primary endpoint. The multicenter, randomized, double-blind, parallel-group, placebo controlled study showed a statistically significant reduction in area under the curve analysis (AUC) of the NRS scores in the subjects receiving EXPAREL(TM) compared to placebo (p=0.0005) over the first 24 hours following surgery; the difference continued to be statistically significant through 36 hours. Pain scores in both groups declined after 36 hours.

The study also met secondary endpoints with statistical significance favoring EXPAREL(TM) for the percentage of patients who were pain free through 8 hours and at 48 hours; the percentage of patients who received no rescue medication through 24 hours; and the total amount of rescue required by 24 hours. EXPAREL(TM) appeared to be well tolerated , with the incidence of adverse events similar to placebo. No serious adverse events were reported in patients receiving EXPAREL(TM).

The Phase III trial studied 193 subjects in four U.S. centers to determine the safety and efficacy of a single administration of EXPAREL(TM) for prolonged postoperative analgesia in subjects undergoing first metatarsal osteotomy (bunionectomy).

"The opportunity to provide a non-opioid platform with Exparel as part of a multi-modal regimen for postoperative pain addresses a significant need in the acute care market. The reduction of opioid use in the bunionectomy trial is an important outcome since opioid usage is associated with side effects such as sedation, nausea, vomiting and respiratory depression," commented Gary Patou, MD and Chief Medical Officer for Pacira.

The Company expects to receive Phase III data on a hemorrhoidectomy trial by the end of 2009.

EXPAREL, a proprietary product of Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained-release formulation of bupivacaine HCL, a local anesthetic widely used for treating postoperative pain. EXPAREL is the latest product to benefit from Pacira's 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.

About Pacira

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 for postsurgical pain. EXPAREL 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 clinical development and all pipeline materials.

Source: Pacira Pharmaceuticals, Inc