SAN DIEGO and PARSIPPANY, N.J., March 2, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that positive results from its Phase 1 study evaluating EXPAREL™ (bupivacaine extended-release liposome injection) in patients with moderate hepatic impairment, will be presented at the 2011 American Society for Clinical Pharmacology and Therapeutics (ASCPT) 112th Annual Meeting in Dallas, TX. Results from this Phase 1, open-label, parallel-group volunteer study demonstrated that the differences in plasma exposure of EXPAREL between subjects with moderate, stable hepatic impairment compared to subjects with normal hepatic function were small and unlikely to require a dose adjustment of EXPAREL.
The details for the Pacira poster presentation are as follows:
Date& Time: Thursday, March 3, 2011 from 7:30-9:30 a.m. (CST)
Poster Number: PI-67
Poster Title: Pharmacokinetics of Depobupivacaine (EXPAREL), a Novel Bupivacaine Extended-Release Liposomal Injection in Volunteers with Moderate Hepatic Impairment
Presenter: Erol Onel, MD, executive medical director, at Pacira Pharmaceuticals, Inc.
Following the presentation, the full poster will be available on Pacira's 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) goal 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 from phase 3 trial 316 demonstrates that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. The package insert for bupivacaine indicates it provides anesthesia for up to 7 hours. 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, manufacture, and commercialization 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 investigational 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.
Any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL's potential, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully obtain regulatory approval for EXPAREL; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses and our ability to raise substantial additional funds to achieve our goals; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of the final prospectus relating to our initial public offering filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
James S. Scibetta, CFO, Pacira Pharmaceuticals, Inc.
Jennifer Beugelmans, Investor Relations, Pure Communications Inc.
SOURCE Pacira Pharmaceuticals, Inc.