|View printer-friendly version|
|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:
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.
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.
Jennifer Beugelmans, Investor Relations, Pure Communications Inc.