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|Pacira Pharmaceuticals, Inc. Announces Key EXPAREL™ Data to be Presented at American College of Surgeons 97th Annual Clinical Congress|
PARSIPPANY, N.J., Oct. 18, 2011 /PRNewswire via COMTEX/ --
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that new data discussing the pharmacoeconomic impact of EXPAREL™ (bupivacaine liposome extended-release injectable suspension), the company's lead investigational product for postsurgical pain management, will be presented during a podium presentation at the American College of Surgeons (ACS) 97th Annual Clinical Congress in San Francisco on Wednesday, October 26. Another podium presentation highlighting the pain control properties and related impact on opioid use of EXPAREL compared to bupivacaine HCl across three surgical models will be presented on Monday, October 24.
Currently under review with the U.S. Food and Drug Administration, EXPAREL is an innovative, long-acting bupivacaine that has been evaluated in multiple Phase 2 and Phase 3 clinical studies to assess prolonged postsurgical analgesia for up to 72 hours with a single-dose local administration into the surgical site. The drug combines bupivacaine with DepoFoam®, Pacira's proven product delivery technology that delivers medication over a desired time period.
The schedule for Pacira podium presentations are as follows:
Presentation Title: Comparison of Immediate-Release Bupivacaine vs. EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) on Opioid Requirements and Related Adverse Events from Phase 2 and 3 Studies Utilizing Multimodal Analgesia Across Multiple Surgical Models
Presented by: Sonia Ramamoorthy, M.D., associate professor of surgery at the University of California, San Diego
Date & Time:Monday, October 24 from 9:45-11:15 a.m. PDT
Location: Moscone Convention Center, Moscone West, 3rd Floor, Room 3014/3016/3018
Presentation Title: EXPAREL™ (Bupivacaine Extended-Release Liposome Injection), an Investigational Multi-Vesicular Liposomal Bupivacaine Based Analgesic, Decreases Pain, Opioid Use, and Opioid-Related Adverse Events for Three Days Post Surgery
Presented by: Stephen R. Gorfine, M.D., clinical professor of surgery, Mount Sinai School of Medicine
Date & Time:Wednesday, October 26 from 4:15-5:45 p.m. PDT
Location: Moscone Convention Center, Moscone North, Exhibition Level, Room 134
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. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL (bupivacaine liposome extended-release injectable suspension), the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive Phase 3 clinical development for postsurgical 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 http://www.pacira.com/.
EXPAREL (bupivacaine liposome extended-release injectable suspension) 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. Market data indicate that there is an unmet medical need for a longer-acting anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. 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.
Forward Looking Statements
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: the timing of, and our ability to obtain regulatory approval of EXPAREL; the timing of our anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2010, 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
SOURCE Pacira Pharmaceuticals, Inc.