Multicenter randomized study serves as
unequivocal evidence of EXPAREL as an opioid minimizing agent in a
complex and painful surgical procedure
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) announced that its Phase
4 study of EXPAREL® (bupivacaine liposome injectable suspension) in
patients undergoing total knee arthroplasty (TKA) achieved
statistical significance for its co-primary endpoints for
postsurgical pain and opioid reduction. EXPAREL also achieved
statistical significance for certain key secondary endpoints,
including time to first opioid use and the percentage of patients
who did not require any opioid to treat their postsurgical pain.
The company is completing its analyses of additional secondary
endpoints. The results from the study will be submitted as a series
of publications in the peer-reviewed medical literature later this
year.
The co-primary efficacy endpoints were the area
under the curve (AUC) of the pain intensity scores measured on a
visual analog scale (VAS) from 12 to 48 hours after surgery and the
total opioid consumption expressed as morphine equivalents from
zero to 48 hours after surgery. The EXPAREL group achieved a
statistically significant reduction in pain scores compared to the
group who did not receive EXPAREL (p=0.0381). Additionally,
patients who received EXPAREL consumed significantly fewer opioids
than patients who did not receive EXPAREL during the 48 hours that
followed surgery (p=0.0048).
Sixteen centers participated in this trial with 139
patients randomized to an EXPAREL-based or a bupivacaine-based
multimodal pain regimen of oral acetaminophen, celecoxib and
pregabalin. In addition, all patients received intravenous
tranexamic acid at the beginning of surgery or
intra-operatively.
The study showed the EXPAREL group achieved
statistically significant differences compared to the group who did
not receive EXPAREL for the following key secondary endpoints:
- The percentage of patients who were opioid-free through 48
hours
- The average time to first use of an opioid rescue
medication
“The operating room is the gateway to opioid abuse
and places patients at serious risk for addiction and dependence,”
said Dave Stack, chairman and chief executive officer of Pacira.
“The results of this study provide further evidence that EXPAREL
effectively reduces, and in some cases, eliminates the use of
opioids while providing prolonged postsurgical pain relief to
patients undergoing complex and painful knee replacement surgery
with a simple inexpensive multimodal design. A recent survey
determined that one in 10 opioid naïve patients are opioid
dependent six months after opioid-driven postsurgical pain
management – we believe EXPAREL can play a critical role in taking
on this national issue.”1
This Phase 4 study was a multicenter, randomized,
double-blind, controlled, parallel group study. Patients were
randomized to receive local infiltration analgesia with 266 mg of
EXPAREL admixed with bupivacaine and expanded in volume to 120 mL
(20 mL EXPAREL vial admixed with 20 mL standard bupivacaine 0.5%
and expanded with 80 mL normal saline) to local infiltration
analgesia with bupivacaine expanded in volume to 120 mL (20 mL
standard bupivacaine 0.5% and expanded with 100 mL normal saline).
Investigators administered study drug using six 20 mL
prefilled syringes.
To support optimal and replicable outcomes in TKA,
this study used a standardized infiltration protocol designed by
experienced clinicians to define best practice technique for
administering EXPAREL. Key features of the infiltration protocol
include volume expansion to ensure full coverage of the nerve
fibers responsible for sending pain signals to the brain, admixing
with free bupivacaine to provide sufficient immediate pain relief,
and a clear definition of the sites for infiltration and
administration technique to ensure adequate coverage of the
impacted nerve fibers.
Pacira and its partner, DePuy Synthes companies of
Johnson and Johnson, are supporting a number of educational
programs for best practice EXPAREL technique in orthopedic
procedures. At the American Academy of Orthopaedic Surgeons
Annual Meeting taking place in San Diego March 14-18, the companies
will host innovative virtual reality experiences for clinicians to
enhance their infiltration technique based on the protocol from the
Phase 4 study of EXPAREL in TKA.
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 http://www.exparel.com/hcp/pdf/EXPAREL_Prescribing_Information.pdf.
Important Safety Information
EXPAREL 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.
Please see the full Prescribing Information for
more details available at:
http://www.exparel.com/hcp/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any 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
plans to continue to manufacture and provide support services for
our commercial partners who have licensed DepoCyt(e); 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.
References
1. “Volleyball Legend Gabrielle Reece on Knee
Replacement, Managing Pain, Olympics and More.” USA Today, 28
September 2016.
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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