Pacira Pharmaceuticals Announces FDA Acceptance of sNDA for EXPAREL as a Nerve Block to Produce Regional Analgesia
October 18 2017 - 7:30AM
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced the U.S.
Food and Drug Administration (FDA) has accepted the resubmission of
its supplemental new drug application (sNDA) seeking expansion of
the EXPAREL® (bupivacaine liposome injectable suspension) label to
include administration via nerve block for prolonged regional
analgesia. The expected action date by the FDA under the
Prescription Drug User Fee Act (PDUFA) is April 6, 2018.
The sNDA is based on the positive data from a Phase 3 study of
EXPAREL in femoral nerve block for TKA (lower extremity) and a
Phase 3 study of EXPAREL in brachial plexus block for shoulder
surgeries (upper extremity). It also includes safety and
pharmacokinetic data through 120 hours.
“We believe our filing contains all of the necessary information
to satisfy the FDA requirements, namely another clinical trial that
establishes the efficacy of EXPAREL in a clinical setting beyond
femoral nerve block, as well as a robust safety database that
includes pharmacokinetic profiles through the median time to
maximum concentration of EXPAREL,” said Dave Stack, chairman and
chief executive officer at Pacira. “We look forward to working with
the FDA to offer clinicians an additional option to provide
postsurgical patients with long-lasting non-opioid pain control, in
order to both reduce opioid requirements and support the increasing
clinical goal of transitioning inpatient procedures to an
outpatient setting.”
Eight Pacira-sponsored studies support this expanded indication.
In total, 570 subjects received a dose of EXPAREL ranging from 2 mg
to 310 mg. In addition, the sNDA includes data from two
investigator-initiated studies that provide additional experience
in smaller, peripheral nerve block settings.
About Pacira 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
flagship product, EXPAREL® (bupivacaine liposome injectable
suspension), indicated for single-dose infiltration into the
surgical site to produce postsurgical analgesia, was commercially
launched in the United States in April 2012. EXPAREL and two other
products have successfully utilized 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. Additional information about Pacira is
available at 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 period of time. 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 InformationEXPAREL is
contraindicated in obstetrical paracervical block anesthesia.
EXPAREL has not been studied for use in patients younger than 18
years of age. 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. Other formulations of bupivacaine should not be
administered within 96 hours following administration of EXPAREL.
Monitoring of cardiovascular and neurological status, as well as
vital signs should be performed during and after injection of
EXPAREL as with other local anesthetic products. 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. In clinical
trials, the most common adverse reactions (incidence greater-than
or equal to 10%) following EXPAREL administration were nausea,
constipation, and vomiting.
Forward Looking StatementsAny statements in
this press release about our 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 our sales and manufacturing efforts in support
of the commercialization of EXPAREL; the rate and degree of market
acceptance of EXPAREL and our other products; the size and growth
of the potential markets for EXPAREL and our ability to serve those
markets; our 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; our plans to evaluate, develop and pursue additional
DepoFoam-based product candidates; clinical trials in support of an
existing or potential DepoFoam-based product; our commercialization
and marketing capabilities; our and Patheon UK Limited’s ability to
successfully and timely construct dedicated EXPAREL manufacturing
suites; and other factors discussed in the “Risk Factors” of our
most recent Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 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. Important factors could cause our actual results to
differ materially from those indicated or implied by
forward-looking statements, and as such 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.
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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