Pacira Pharmaceuticals Statement on FDA Advisory Committee for EXPAREL® for Use as a Nerve Block to Produce Regional Analges...
16 February 2018 - 7:34AM
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX), announced today that
the U.S. Food and Drug Administration’s (FDA) Anesthetic and
Analgesic Drug Products Advisory Committee did not reach a
unanimous decision on the efficacy and safety of the use of
EXPAREL® (bupivacaine liposome injectable suspension) as a nerve
block to produce regional analgesia. The committee’s feedback will
be considered by the FDA in its review of the company’s sNDA
seeking expansion of the EXPAREL label. The Prescription Drug User
Fee Act (PDUFA) date for completion of the review is April 6,
2018.
Four committee members voted to recommend FDA approval of the
EXPAREL sNDA while six believed that more research is needed to
further support the proposed new indication.
“We remain confident that the data from our clinical program
provides all of the necessary information to support expansion of
the current EXPAREL label for infiltration to also include use as a
nerve block for regional analgesia,” said Dave Stack, chairman and
chief executive officer at Pacira Pharmaceuticals. “We look forward
to working with the FDA to address any outstanding questions as we
move through the sNDA review process toward our ultimate goal of
offering additional flexibility in the way EXPAREL can be
administered so that clinicians and patients alike have increased
opportunity to realize the benefits of long-lasting non-opioid pain
control.”
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 EXPAREL 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.
EXPAREL is currently indicated for infiltration into the
surgical site to produce postsurgical analgesia and has been used
in over 3.5 million patients across the United States.
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.
About EXPAREL® EXPAREL (bupivacaine liposome
injectable suspension) is currently 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. By utilizing the DepoFoam
platform, a single dose of EXPAREL delivers bupivacaine over time,
providing significant reductions in cumulative pain score with up
to a 45 percent decrease in opioid consumption; the clinical
benefit of the opioid reduction was not demonstrated. Additional
information is available at www.EXPAREL.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) 451-4030
susan.mesco@pacira.com
Media Contact:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
aschneider@coynepr.com
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