Pacira Announces FDA Advisory Committee Meeting to Review sNDA for EXPAREL® as a Nerve Block for Regional Analgesia
November 14 2017 - 7:30AM
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the
U.S. Food and Drug Administration (FDA) has notified the company
that its supplemental New Drug Application (sNDA) for EXPAREL®
(bupivacaine liposome injectable suspension) as a nerve block for
regional analgesia will be discussed at a meeting of the Anesthetic
and Analgesic Drug Products Advisory Committee (AADPAC). The
meeting is tentatively scheduled for February 14-15, 2018. A
definitive date for the advisory committee meeting is expected to
be published by FDA in the Federal Register at least 15 days prior
to such meeting. The Prescription Drug User Fee Act (PDUFA) goal
date for completion of review by FDA of April 6, 2018 remains
unchanged.
“We believe our robust dataset supports the expansion of the
EXPAREL label to include nerve block and we look forward to a
productive discussion with the advisory committee,” said Dave
Stack, chairman and chief executive officer of Pacira. “We remain
steadfast in our commitment to continuing to work closely with the
FDA toward our common goal of ensuring patients have access to safe
and effective non-opioid treatments for postsurgical pain.”
The sNDA filing is based on positive data from a Phase 3 study
of EXPAREL in femoral nerve block for total knee arthroplasty
(lower extremity) and a Phase 3 study of EXAREL in brachial plexus
block for shoulder surgeries (upper extremity). It includes data
from eight company-sponsored studies with safety and
pharmacokinetic data through 120 hours. In addition, the sNDA
includes data from two investigator-initiated studies that provide
additional experience in smaller, peripheral nerve block
settings.
The AADPAC reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in anesthesiology and surgery and makes
appropriate recommendations to the Commissioner of Food and
Drugs.
About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty
pharmaceutical company dedicated to advancing and improving
postsurgical outcomes for acute care practitioners and their
patients. The company’s flagship product, EXPAREL® (bupivacaine
liposome injectable suspension) was commercially launched in the
United States in April 2012. EXPAREL utilizes DepoFoam®, a unique
and proprietary product delivery technology that encapsulates drugs
without altering their molecular structure, and releases them over
a desired period of time. To learn more about Pacira, including the
corporate mission to reduce overreliance on opioids, visit
www.pacira.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block
anesthesia. In clinical trials, the most common adverse reactions
(incidence ≥10%) following EXPAREL administration were nausea,
constipation, and vomiting. EXPAREL is not recommended to be used
in the following patient population: patients <18 years old
and/or pregnant patients. Because amide-type local anesthetics,
such as bupivacaine, are metabolized by the liver, EXPAREL should
be used cautiously in patients with hepatic disease. Patients with
severe hepatic disease, because of their inability to metabolize
local anesthetics normally, are at a greater risk of developing
toxic plasma concentrations. EXPAREL is not recommended for the
following types or routes of administration: epidural, intrathecal,
regional nerve blocks, or intravascular or intra-articular use.
Non-bupivacaine-based local anesthetics, including lidocaine, may
cause an immediate release of bupivacaine from EXPAREL if
administered together locally. The administration of EXPAREL may
follow the administration of lidocaine after a delay of 20
minutes or more. Formulations of bupivacaine other than
EXPAREL should not be administered within 96 hours following
administration of EXPAREL. Central Nervous System (CNS) Reactions:
There have been reports of adverse neurologic reactions with the
use of local anesthetics. These include persistent anesthesia and
paresthesias. CNS reactions are characterized by excitation and/or
depression. Cardiovascular System Reactions: Toxic blood
concentrations depress cardiac conductivity and excitability which
may lead to dysrhythmias sometimes leading to death. Allergic
Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema)
are rare and may occur as a result of hypersensitivity to the local
anesthetic or to other formulation ingredients. Chondrolysis: There
have been reports of chondrolysis (mostly in the shoulder joint)
following intra-articular infusion of local anesthetics, which is
an unapproved use.
Forward Looking Statements
Any statements in this press release about the company’s future
expectations, plans, outlook and prospects, and other statements
containing the words “believes,” “anticipates,” “plans,”
“estimates,” “expects,” “intends,” “may” 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 success of the company’s sales and
manufacturing efforts in support of the commercialization of
EXPAREL; the rate and degree of market acceptance of EXPAREL and
the company’s other products; the size and growth of the potential
markets for EXPAREL and the company’s ability to serve those
markets; the company’s plans to expand the use of EXPAREL to
additional indications and opportunities, and the timing and
success of any related clinical trials; the related timing and
success of United States Food and Drug Administration supplemental
New Drug Applications; the outcome of the U.S. Department of
Justice inquiry; the company’s plans to evaluate, develop and
pursue additional DepoFoam-based product candidates; clinical
trials in support of an existing or potential DepoFoam-based
product; the company’s commercialization and marketing
capabilities; the company’s and Patheon UK Limited’s ability to
successfully and timely construct dedicated EXPAREL manufacturing
suites; and other factors discussed in the “Risk Factors” of the
company’s most recent Annual Report on Form 10-K for the fiscal
year ended December 31, 2016 and in other filings that the company
periodically makes with the SEC. In addition, the forward-looking
statements included in this press release represent the company’s
views as of the date of this press release. Important factors could
cause actual results to differ materially from those indicated or
implied by forward-looking statements, and as such the company
anticipates that subsequent events and developments will cause its
views to change. However, while the company may elect to update
these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing the company’s views as of any date subsequent to the
date of this press release.
Company Contact:Pacira Pharmaceuticals,
Inc.Susan Mesco (973) 451-4030susan.mesco@pacira.com
Media Contact:Coyne Public RelationsAlyssa Schneider (973)
588-2270aschneider@coynepr.com
Pacira BioSciences (NASDAQ:PCRX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pacira BioSciences (NASDAQ:PCRX)
Historical Stock Chart
From Sep 2023 to Sep 2024