Phase III Studies of EXPAREL(TM) (DepoBupivacaine) from Pacira Complete Enrollment
acute care specialty pharmaceutical company, announced today that enrollment
has been completed in two pivotal Phase III SIMPLE trials to evaluate the
safety and efficacy of a single intraoperative administration of EXPAREL(TM)
(DepoBupivacaine) for prolonged postoperative analgesia.
Results from the studies in hemorrhoidectomy and in total knee
arthroplasty (TKA) are expected to provide the primary clinical data, in
addition to extensive existing preclinical and clinical data, for a planned
2009 NDA filing under U.S. Food and Drug Administration 505 (b)(2)
regulations.
(Logo: http://www.newscom.com/cgi-bin/prnh/20070618/PACIRALOGO)
EXPAREL, a proprietary product from Pacira Pharmaceuticals, is a novel
long-acting, sustained-release formulation of bupivacaine, a local anesthetic
widely used for treating postoperative pain. EXPAREL is being studied in
several different types of surgical procedures where postoperative pain
management is especially problematic and where the need for prolonged
analgesia with a single intraoperative administration can provide a
significant improvement in pain relief — especially during the first 72-hours
following surgery — while also minimizing the need for opioids. With
improved prolonged postoperative pain management and a reduction in opioid
consumption, Pacira believes patients treated with EXPAREL will experience
better pain management and have fewer opioid-related side effects such as
nausea and vomiting, and improved outcomes overall.
Recently, Pacira reported the results of a Phase II TKA study of EXPAREL
at the
showed the new sustained-release analgesic significantly reduced postoperative
pain, opioid use, and reduced opioid-related adverse events compared to the
gold standard pain medication.
Pacira is seeking a co-promotion partner for EXPAREL in
Outside
in both human and animal health applications. In
intends to commercialize EXPAREL and its proprietary pipeline products within
specialty acute care. Partnerships in the U.S. for both human and animal
health to expand the commercialization are currently in development. EXPAREL
is the latest product to benefit from Pacira’s proprietary sustained-release
DepoFoam(R) technology. DepoFoam technology is designed to address the
limitations of widely used medications by enhancing their dosing and/or
administration profile. It achieves this by encapsulating the drug in
multivesicular liposomal particles which then release the drug over a desired
period of time without altering the drug molecule. DepoFoam is a proven
technology that is already used in two commercially available products in the
U.S. and
About Pacira
Pacira Pharmaceuticals, Inc. is an acute care specialty pharmaceutical
company founded in March, 2007 through the acquisition of the former
SkyePharma PLC injectable business, for which an experienced management team
was assembled to address the needs of the acute care market. The company’s
most advanced product, EXPAREL(TM) (DepoBupivacaine), a bupivacaine-based
product intended to deliver postoperative pain relief by infiltration, is in
late Phase III clinical development. Pacira also plans to study EXPAREL for
nerve block, non-surgical pain such as long bone fracture and for
intraarticular injection. EXPAREL benefits from the proprietary DepoFoam
Technology owned by Pacira. Two other DepoFoam-based products — DepoDur(R)
and DepoCyt/DepoCyte(R) — are marketed by partners in several global
territories. The DepoFoam technology also forms the basis of multiple
development projects providing Pacira an opportunity to expand its pipeline.
Pacira owns two cGMP production facilities which produce the two approved
products, EXPAREL clinical development and all pipeline materials.
Additional information about Pacira is available at http://www.pacira.com.
This news release contains forward-looking statements that involve risks
and uncertainties, including statements relating to initiation and progress of
the Company’s clinical trial programs and the preliminary results from the
clinical trials. Actual results could differ materially from those projected
and the Company cautions readers not to place undue reliance on the forward-
looking statements contained in the release and anticipated presentation.
Pacira Contact:
Vice President, Commercial Development
973-254-3565
SOURCE Pacira Pharmaceuticals, Inc.