Expected PDUFA Date of March 5, 2015
PARSIPPANY, N.J.--(BUSINESS WIRE)--May 7, 2014--
Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the submission
of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug
Administration (FDA) for a nerve block indication for EXPAREL®
(bupivacaine liposome injectable suspension). The sNDA is based on
positive data from a Phase 3 study assessing the safety and efficacy of
EXPAREL in femoral nerve block for total knee arthroplasty, and will
also include additional safety data from a Phase 3 study of EXPAREL used
to perform an intercostal nerve block for thoracotomy.
The timeline for review of the sNDA, under the Prescription Drug User
Fee Act (PDUFA), is 10 months. If the FDA accepts the sNDA filing, a
PDUFA target date of March 5, 2015 is expected.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a specialty
pharmaceutical company focused on the clinical and commercial
development of new products that meet the needs of acute care
practitioners and their patients. The company’s current emphasis is the
development of non-opioid products for postsurgical pain control, and
its lead product, EXPAREL® (bupivacaine liposome injectable suspension),
was commercially launched in the United States in April 2012. EXPAREL
and two other products have utilized the Pacira proprietary product
delivery technology DepoFoam®, a unique platform that encapsulates drugs
without altering their molecular structure and then releases them over a
desired period of time. Additional information about Pacira is available
EXPAREL (bupivacaine liposome injectable suspension) is indicated for
single-dose infiltration into the surgical site to produce postsurgical
analgesia. The product combines bupivacaine with DepoFoam, a proven
product delivery technology that delivers medication over a desired time
period. EXPAREL represents the first and only multivesicular liposome
local anesthetic that can be utilized in the peri- or postsurgical
setting in the same fashion as current local anesthetics. By utilizing
the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine
over time, providing analgesia with reduced opioid requirements for up
to 72 hours. Pivotal studies have demonstrated the safety and efficacy
of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy
procedures and additional studies are underway to further demonstrate
the safety and efficacy in other procedures. Additional information is
available at www.EXPAREL.com.
Source: Pacira Pharmaceuticals, Inc.
Pacira Pharmaceuticals, Inc.
Susan Heins, 864-286-9597