Navigation Links
Pacira Pharmaceuticals, Inc. Announces FDA Extension of EXPAREL™ PDUFA Target Date by Three Months
Date:6/14/2011

PARSIPPANY, N.J., June 14, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) by three months. The new PDUFA goal date is October 28, 2011.

The FDA requested additional information from Pacira, which the company has submitted. The FDA determined that this information constituted a major amendment. The agency has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide the FDA time to complete the review.

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, 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 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.

About EXPAREL™

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 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

Jennifer Beugelmans
Vice President, Investor Relations
Pure Communications, Inc.
(646) 596-7473

Dan Budwick
Vice President, Media Relations
Pure Communications, Inc.
(973) 271-6085


'/>"/>
SOURCE Pacira Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Pacira Pharmaceuticals, Inc. Appoints Two Life Sciences Industry Veterans to Its Board of Directors
2. Pacira Pharmaceuticals, Inc. to Present at UBS Global Specialty Pharmaceuticals Conference
3. Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations at the International Anesthesia Research Society 2011 Annual Meeting
4. Pacira Pharmaceuticals, Inc. Announces Phase 3 EXPAREL™ Data Presentation at the American Society of Colon and Rectal Surgeons 2011 Annual Meeting
5. Pacira Pharmaceuticals, Inc. Reports First Quarter 2011 Financial Results
6. Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations
7. Pacira Pharmaceuticals, Inc. Announces Timing for First Quarter 2011 Financial Results Webcast and Conference Call
8. Pacira Pharmaceuticals to Present at BioCentury Future Leaders in the Biotech Industry Conference
9. Pacira Pharmaceuticals Reports Fourth Quarter and 2010 Financial Results
10. Pacira Pharmaceuticals to Present at the Barclays Capital 2011 Global Healthcare Conference
11. Pacira Pharmaceuticals EXPAREL™ Data to be Featured at 2011 ASCPT 112th Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/19/2017)... 19, 2017  nThrive™, an independent Patient-to-Payment? solutions ... thought leadership at the 2017 HIMSS Conference. The ... award from KLAS. nThrive will host ... how market trends shape the holistic, integrated revenue ... comprehensive Patient Access solution. The panel will reveal ...
(Date:2/18/2017)... DUBLIN , Feb. 17, 2017 Research and ... Business Report" report to their offering. ... The report provides separate comprehensive analytics for the US, ... Europe , Asia-Pacific , Latin America ... for the period 2015 through 2022. Also, a six-year historic analysis is ...
(Date:2/17/2017)... -- According to a new market research report "Particle ... (Cleanroom Monitoring, Contamination Monitoring of Liquids), and End User (Healthcare Industry, ... market is expected to reach USD 330.6 Million by 2021 from ... 2016 to 2021. Continue Reading ... ...
Breaking Medicine Technology:
(Date:2/20/2017)... ... February 20, 2017 , ... ReportingMD, a Population Health Software Company, is pleased to ... company. The new location will triple the size of the previous location while bringing ... of Sunapee, NH. , “We are excited to expand our footprint to better ...
(Date:2/20/2017)... Tampa, FL (PRWEB) , ... February 20, 2017 ... ... $20,000 gift from Constellation Brands to purchase a new ultrasound-enhanced thrombolysis machine, a ... ultrasonic waves. The gift was facilitated by the Pepin Family Foundation. , “We ...
(Date:2/19/2017)... ... February 19, 2017 , ... Orbita, ... will join forces with Healthwise ® at HIMSS 2017 to ... leader in evidence-based health education, technology and services, will demonstrate a voice-powered knowedge ...
(Date:2/18/2017)... ... ... Park Cities Pet Sitter President, Joette White, has been featured on Episode ... The episode, which was posted this week, features a 30-minute interview of White by ... Pet Sitter’s being awarded the 2017 National Association of Professional Pet Sitter’s Business of ...
(Date:2/17/2017)... ... February 17, 2017 , ... The Alliance Healthcare Foundation (AHF) ... further positively impact the health and wellness of our community in San Diego ... duty to seriously consider releasing our assets beyond our 5% targeted distribution each ...
Breaking Medicine News(10 mins):