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Pacira Pharmaceuticals Presents New Data from EXPAREL Phase 3 Study at Orthopaedic Research Society’s 57th Annual Meeting
Data Demonstrates that Patients Treated with EXPAREL Were Able to Forgo Opioid Rescue Medications for a Longer Time Period Following Surgery than Patients Treated with Placebo
Parsippany, NJ – January 13, 2011 - Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that new data from its Phase 3 bunionectomy study to evaluate the efficacy and safety of the intraoperative administration of EXPAREL™ (bupivacaine extended-release liposome injection) is being presented in a poster session (number AAOS7) at the 57th Annual Meeting of the Orthopaedic Research Society held from January 13-16, 2011 in Long Beach, California. Study results from this multicenter, randomized, double-blind, parallel-group, placebo-controlled bunionectomy trial demonstrate that the median time to first use of opioid rescue medication was 7.2 hours for patients treated with EXPAREL compared with 4.3 hours for patients treated with placebo (p<0.0001).
The Phase 3 trial studied 193 subjects in four U.S. centers to determine the safety and efficacy of a single administration of EXPAREL for prolonged postoperative analgesia in subjects undergoing first metatarsal osteotomy (bunionectomy).
Previously disclosed Phase 3 findings in this study showed EXPAREL met its primary endpoint, with a statistically significant reduction in area under the curve analysis (AUC) of the pain intensity numeric rating scale (NRS) scores in subjects receiving EXPAREL compared with placebo (p=0.0005) over the first 24 hours following surgery. EXPAREL is a novel long-acting, sustained-release analgesic formulation of bupivacaine HCl. Bupivacaine HCl is widely used for treating postsurgical pain.
Additional key findings from the Phase 3 study being presented include:
- A larger percentage of patients treated with EXPAREL avoided opioid rescue medication during the first 24 hours after surgery compared to placebo (7% vs. 1%; p<0.05);
- Statistically, significantly more patients treated with EXPAREL were pain-free at 2, 4, 8 and 48 hours compared to placebo (p<0.05);
- Statistically, significantly less opioids were consumed over the first 24 hours after surgery in the EXPAREL group (p=0.0077);
- EXPAREL was well tolerated in patients who received postsurgical treatment for pain following bunionectomy; 59.8% of patients treated with EXPAREL experienced an adverse event compared to 67.7% of patients treated with placebo;
- Most of the adverse events were not considered related to study drug and were mild or moderate in severity.
The full poster can be found on the Pacira website at www.pacira.com.
In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL had been accepted for filing by the U.S. Food and Drug Administration (FDA). Pacira submitted the EXPAREL NDA in September 2010 for the initial indication of postsurgical analgesia by local administration. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 28, 2011 for the review of the EXPAREL NDA.
EXPAREL is Pacira’s proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and demonstrate statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data has also demonstrated that EXPAREL provides analgesia for up to 72 hours post-surgery compared with 7 hours or less for bupivacaine. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, commercialization and manufacture of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. The company's most advanced product candidate, EXPAREL, a bupivacaine-based product, has completed Phase 3 clinical development for postoperative analgesia by infiltration. EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at www.pacira.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
James S. Scibetta, CFO, Pacira Pharmaceuticals, Inc.
Jennifer Beugelmans, Investor Relations, Pure Communications Inc.