Data From Two-Year Follow-up Study Assessing EXPAREL Safety in Breast Augmentation Surgery Using Silicone Implant Also Presented
DENVER and PARSIPPANY, N.J., Sept. 26, 2011 /PRNewswire via COMTEX/ -- Pacira Pharmaceuticals, Inc. PCRX today announced that the company's lead investigational product for postsurgical pain management, EXPAREL(TM) (bupivacaine liposome extended-release injectable suspension), was highlighted in the "Hot Topics in Plastic Surgery" panel at the annual scientific assembly of the American Society of Plastic Surgeons (ASPS) in Denver, Colo. In addition, new data demonstrating the long-term safety of EXPAREL following augmentation mammoplasty (breast augmentation) using silicone implants were presented during an oral session at ASPS.
Currently under review with the U.S. Food and Drug Administration, EXPAREL is an innovative long-acting bupivacaine that has been shown in multiple Phase 2 and Phase 3 clinical studies to provide prolonged postsurgical analgesia for up to 72 hours with a single-dose local administration at the surgical site. The drug combines bupivacaine with DepoFoam®, a proven product delivery technology that encapsulates medications and delivers them over a desired time period.
Richard A. Baxter, M.D., a practicing plastic surgeon in the Seattle area and former president of the Washington Society of Plastic Surgeons and the Northwest Society of Plastic Surgeons, presented an overview of EXPAREL, including the clinical efficacy data to date, at the "Hot Topics in Plastic Surgery" panel on Friday, September 23, 2011.
"Patient safety, comfort and satisfaction are of primary importance to surgeons and to the success of their practices," said Dr. Baxter. "The thought of postsurgical pain is one of the biggest impediments for patients considering elective operations such as cosmetic plastic surgery. Traditional opioid medications have a long list of drawbacks including nausea, constipation and inconsistent pain relief, so a new therapy like EXPAREL, which blocks the pain at its source for up to three days and potentially reduces the need for opioids, could be a game changer."
Also at ASPS, new data from a two-year observational study of EXPAREL following breast augmentation were presented during an oral session on Saturday, September 24, 2011. The study, a long-term follow-up of 94 subjects enrolled in prior Phase 2 and Phase 3 studies who underwent breast augmentation at multiple sites in the U.S. and received either bupivacaine or EXPAREL, evaluated patients from 13 to 24 months following surgery; new key finding include:
EXPAREL did not have any impact on normal healing in the presence of silicone breast implant material.
There was no meaningful difference in impact on breast appearance or implant material in the bupivacaine versus EXPAREL groups.
Neither EXPAREL nor bupivacaine were associated with any serious adverse events, deaths or withdrawals from the study.
"EXPAREL represents a much needed advance in perioperative, site-specific pain relief therapies, and this study demonstrates the long-term safety profile of EXPAREL following breast augmentation," said Harold Minkowitz, M.D., the study's lead author and a staff anesthesiologist at Memorial Hermann Memorial City Medical Center in Houston, Texas. "After evaluating patients for up to two years after the procedure, we concluded that EXPAREL did not interfere with the patient's healing process or the integrity of the implant material, and was not associated with any late-stage adverse events."
According to the ASPS, breast augmentation has been the most performed cosmetic surgical procedure since 2006. In 2010, approximately 296,000 breast augmentations were performed, 60 percent of which used silicone implants.(1) In the last decade, the number of breast augmentations performed has increased by 39 percent.(1)
"We are pleased to present these data that reinforce the safety and efficacy of EXPAREL to the plastic surgeon community," said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. "Based upon our market research, we believe that plastic surgeons will have significant and immediate interest in the use of EXPAREL, should it be approved by the FDA later this year, for breast augmentation and abdominoplasty [tummy tuck] surgeries, a market that includes approximately one million annual procedures. Beyond this initial market opportunity, we believe that EXPAREL can address a significant, unmet medical need to provide long-acting non-opioid postsurgical pain relief in more than 24 million procedures per year in the U.S. alone."
For more information or to view the full abstracts, please visit the scientific presentations page located in the investors and media section on the Pacira website at 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 (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 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.
(1) 2010 Quick Facts. Report of the 2010 Plastic Surgery Statistics. American Society of Plastic Surgeons.