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Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations
-- New Phase 3 Data to be Presented at the Society for Ambulatory Anesthesia (SAMBA) 26th Annual Meeting Demonstrate the Utility of EXPAREL In Breast Augmentation Surgery --
-- Preclinical and Phase 1 Clinical Data to be Presented at the American Society of Regional Anesthesia and Pain Medicine (ASRA) 36th Annual Regional Anesthesia Meeting and Workshops Highlight the Safety and Tolerability of EXPAREL --
PARSIPPANY, N.J., May 5, 2011 /PRNewswire via COMTEX/ -- Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that clinical and preclinical data highlighting the safety and efficacy of EXPAREL™ will be presented at two medical meetings.
New Phase 3 data on the use of EXPAREL in the treatment of postsurgical pain after augmentation mammoplasty will be presented by Sergio Bergese, M.D., associate professor of anesthesiology and neurological surgery, The Ohio State University, at the Society for Ambulatory Anesthesia (SAMBA) 26th Annual Meeting in San Antonio on Saturday, May 7, 2011. Dr. Bergese's presentation, titled "EXPAREL™ (Bupivacaine Extended-Release Liposome Injection), An Investigational Analgesic, Provides Postsurgical Pain Relief and Decreased Opioid Use as Demonstrated by Integrated Analysis" evaluated the extent and duration of the analgesic effect of EXPAREL in patients undergoing augmentation mammoplasty, the most commonly performed plastic surgery procedure in the United States.
Key findings from this study include:
- A total of 136 patients were treated at 11 clinical sites in the U.S.
- When the pain score and the opioid usage were combined using the integrated rank analysis of Silverman, statistical significance was achieved at multiple time points (p<0.05)
- The mean total amount of opioid rescue used (morphine equivalents) was lower with EXPAREL at all time points through 96 hours
- The difference between groups was statistically significant for the time intervals of 0-24 hours and 0-48 hours
- The overall incidence of treatment-emergent adverse events was approximately 73% in both treatment groups
- There were no serious adverse events, deaths or withdrawals from the study due to an adverse event in either treatment group
"We are amassing a comprehensive body of evidence that we believe supports the utility of EXPAREL," said David Stack, president and CEO of Pacira Pharmaceuticals. "We are excited to present these new Phase 3 data that favor EXPAREL, including a decrease in the use of opioid rescue medication and improvement of patient satisfaction with non-opioid analgesia. We have thoughtfully built a clinical program focused on obtaining data that will illustrate the utility of EXPAREL within the clinical community and we believe the effective execution of this strategy will encourage rapid adoption for EXPAREL if approved later this year."
Dr. Bergese is also presenting comprehensive, program-wide efficacy and safety data for EXPAREL as demonstrated across numerous Phase 2 and Phase 3 clinical trials. The presentation, also at SAMBA on Saturday, May 7, 2011, is titled, "The Efficacy of EXPAREL™, A Multivesicular Liposomal Extended-Release Bupivacaine."
Pacira also announced that new Phase 1 and preclinical data on EXPAREL, as well as previously presented preclinical data, will be highlighted at the American Society of Regional Anesthesia and Pain Medicine (ASRA) 36th Annual Regional Anesthesia Meeting and Workshops, May 5-8, 2011 in Las Vegas.
- "Duration of Motor vs. Sensory Blockade of EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) and Bupivacaine HCl in a Phase 1 Epidural Study" (Presented by Eugene R. Viscusi, M.D.,Director, Acute Pain Management, Department of Anesthesiology, Thomas Jefferson University)
- "Safety and Tolerability of DepoFoam® Encapsulated Bupivacaine for Intra-articular use in Rabbits and Dogs"
- "Safety Evaluation of DepoFoam® Encapsulated Bupivacaine in Dogs to Assess Inadvertent Intrathecal Injection"
- "DepoFoam® Encapsulated Bupivacaine Technology - Safety and Tolerability Properties in Rabbits and Dogs"
- "The Safety Evaluation of DepoFoam® Encapsulated Bupivacaine Administered by Epidural Nerve Block in Rats and Dogs"
All preclinical data is being presented by Brigitte M. Richard, Ph.D., a development and toxicology consultant to Pacira.
For more information or to view the posters presented, please visit the scientific presentations page located in the investors and media section on the Pacira website at http://www.pacira.com/.
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, 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 July 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive 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 http://www.pacira.com/.
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. 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 demonstrate statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggests 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 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
Chief Financial Officer
Pacira Pharmaceuticals, Inc.
Vice President, Media Relations
Pure Communications, Inc.
SOURCE Pacira Pharmaceuticals, Inc.