PARSIPPANY, N.J., Oct. 11, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that new data highlighting the pain control and pharmacokinetic properties of EXPAREL (bupivacaine liposome extended-release injectable suspension), the company’s lead investigational product for postsurgical pain management, will be presented during poster presentations at the 2011 Annual Meetings of the American Society of Anesthesiologists (ASA) and the American College of Clinical Pharmacy (ACCP) in Chicago and Pittsburgh, respectively.
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®, Pacira’s proven product delivery technology that delivers medication over a desired time period.
“We have continued to execute on our strategy to present EXPAREL clinical data to key medical audiences and we are pleased that these data will be showcased at these important medical meetings,” said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. “We look forward to sharing new comparative data highlighting the pain control advantages that EXPAREL offers, as well as pharmacokinetic data, with the pharmacy and anesthesiology communities, who we believe will find great utility in EXPAREL should it be approved later this year.”
The schedule for Pacira poster presentations at ASA in Chicago is as follows:
Poster Title: Comparison of Immediate-Release Bupivacaine vs EXPAREL (Bupivacaine Liposome Extended-Release Injectable Suspension) on Opioid Requirements and Related Adverse Events From Phase 2 and 3 Studies Utilizing Multimodal Analgesia Across Multiple Surgical Models
Abstract Number: A596
Date & Time:Sunday, October 16, 2011 from 8-11 a.m. (CT)
Location: Hall B2, area G
Poster Title: EXPAREL, a Bupivacaine Extended-Release Multivesicular Liposomal Formulation, Exhibits Pharmacokinetic Properties Consistent With Sustained Release Characteristics
Abstract Number: A1593
Date & Time:Wednesday, October 19, 2011 from 8-11 a.m. (CT)
Location: South Hall, area A
The schedule for Pacira poster presentations at ACCP in Pittsburgh is as follows:
Poster Title: Bupivacaine Extended Release Liposome Injection (DepoFoam® bupivacaine) vs. Bupivacaine HCl: A Meta-analysis of Multimodal Trials of Doses Up to and Including 300 mg
Poster Number: 198
Date & Time:Wednesday, October 19, 2011 from 8-10 a.m. (ET)
Location: Exhibit Hall A
Poster Title: DepoFoam® Bupivacaine (DB; EXPAREL; Bupivacaine Liposome Extended-Release Injectable Suspension) Exhibits Pharmacokinetic Properties Consistent With Sustained-Release Characteristics
Poster Number: 200
Date & Time:Wednesday, October 19, 2011 from 8-10 a.m. (ET)
Location: Exhibit Hall A
Following the meeting, the posters will be available on the scientific presentations page located in the investors and media section on the Pacira website at www.pacira.com.
About Pacira
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.
About EXPAREL
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.
Contacts:
James S. Scibetta
Chief Financial Officer
Pacira Pharmaceuticals, Inc.
(973) 254-3570
Dan Budwick
Vice President, Media Relations
Pure Communications, Inc.
(973) 271-6085
SOURCE Pacira Pharmaceuticals, Inc.
