Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its
commitment to non-opioid pain management and regenerative health
solutions, today announced that the U.S. Food and Drug
Administration (FDA) has approved its supplemental new drug
application (sNDA) to expand the EXPAREL® (bupivacaine liposome
injectable suspension) label to include administration in adults as
an adductor canal block and a sciatic nerve block in the popliteal
fossa.
An adductor canal block is used for anesthesia and analgesia for
surgery of the knee, medial lower leg, and ankle surgeries. A
sciatic nerve block in the popliteal fossa is used for anesthesia
and analgesia for foot, ankle, achilles tendon, and other lower leg
surgeries.
“We are thrilled that today’s approval offers clinicians and
patients another option for achieving long-lasting non-opioid pain
control with EXPAREL and an increased ability to transition
procedures to the ambulatory environment,” said Dave Stack, chief
executive officer and chairman of Pacira BioSciences. “In line
with our corporate mission to provide a non-opioid to as many
patients as possible, this new indication provides additional
flexibility in the use of EXPAREL as a regional analgesic for more
than 3 million lower extremity procedures annually, further
increasing the utility of EXPAREL for major orthopedic
procedures.”
The approval is supported by two successful randomized,
double-blind, active-controlled, multicenter Phase 3 studies
designed to evaluate the efficacy, safety, and pharmacokinetics of
EXPAREL versus bupivacaine HCl. One study evaluated EXPAREL as a
single-dose adductor canal block and the second study evaluated
EXPAREL as a single-dose sciatic nerve block in the popliteal
fossa. Both studies met their primary endpoints by demonstrating a
statistically significant reduction in cumulative pain scores from
0 to 96 hours compared with bupivacaine HCl (P<0.01).
Additionally, EXPAREL achieved statistical significance for the
studies’ secondary endpoint of reduced postsurgical opioid
consumption (P<0.01). EXPAREL as a sciatic nerve block in the
popliteal fossa also achieved statistical significance for the
percentage of opioid-free subjects (P<0.01). In both studies,
EXPAREL maintained a safety profile consistent with bupivacaine
HCl.
“The addition of these new blocks, coupled with the previously
approved interscalene brachial plexus nerve block and the ability
to utilize EXPAREL as a fascial plane block provides clinicians
with a wide array of applications to treat postsurgical pain with
long-lasting, non-opioid analgesia via a single dose
administration,” said Jeffrey Gadsden, MD, Chief of Orthopaedic,
Plastic, and Regional Anesthesiology and Professor of
Anesthesiology at Duke University School of Medicine. “Enhanced
recovery protocols built around EXPAREL regional and fascial plane
blocks continue to play a critical—and expanding—role in achieving
increased clinician and patient preference to avoid opioids and
achieve same-day discharge when appropriate.”
About the Phase 3 Studies
EXPAREL as an adductor canal block
The Phase 3, randomized, double-blind, multicenter,
active-controlled study was designed to evaluate the efficacy,
safety, and pharmacokinetics of EXPAREL admixed with bupivacaine
HCl versus bupivacaine HCl administered as an adductor canal block
for postsurgical analgesia in subjects undergoing primary
unilateral total knee arthroplasty. In total, 166 subjects were
randomized 1:1 to receive either 10 mL (133 mg) of EXPAREL admixed
with 10 mL 0.5% bupivacaine HCl or 10 mL 0.5% of bupivacaine HCl
mixed with 10 mL normal saline. All subjects also received 15 mL of
0.25% bupivacaine HCl via an infiltration between the popliteal
artery and capsule of the knee (iPACK) block. The study’s primary
endpoint was the area under the curve, or AUC, of the Numerical
Rating Scale pain intensity scores from 0 to 96 hours post-surgery
comparing EXPAREL to bupivacaine HCl. Secondary endpoints included
total postsurgical opioid consumption from 0 to 96 hours comparing
EXPAREL to bupivacaine HCl.
EXPAREL as a sciatic nerve block in the popliteal fossa
The Phase 3, randomized, double-blind, active-controlled,
multicenter study was designed to evaluate the efficacy, safety,
and pharmacokinetics of EXPAREL versus bupivacaine HCl administered
as a sciatic nerve block in the popliteal fossa. The study was
conducted in two parts, with Part A completed and analyzed before
enrollment in Part B was initiated.
In total, the study randomized 185 subjects. In Part A, 66
subjects undergoing bunionectomy were randomized 1:1:1 to receive a
sciatic nerve block in the popliteal fossa with a single dose of
EXPAREL 266 mg, EXPAREL 133 mg or 20 mL 0.25% bupivacaine HCl. In
part B, an additional 119 subjects undergoing bunionectomy were
randomized 1:1 to receive a sciatic nerve block in the popliteal
fossa with a single dose of EXPAREL 133 mg or 20 mL 0.25%
bupivacaine HCl. All subjects in Part A and Part B received a Mayo
field block with 20 mL 0.5% bupivacaine HCl after study drug
administration in the operating room immediately prior to surgical
incision. The study’s primary endpoint was the area under the
curve, or AUC, of the Numerical Rating Scale pain intensity scores
from 0 to 96 hours post-surgery comparing EXPAREL to bupivacaine
HCl. Secondary endpoints included total postsurgical opioid
consumption from 0 to 96 hours comparing EXPAREL to bupivacaine HCl
and percent opioid free from 0-96 hours. Pacira has submitted the
full results from the Phase 3 studies for publication in a
peer-reviewed journal.
About Pacira
Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to
providing a non-opioid option to as many patients as possible to
redefine the role of opioids as rescue therapy only. The company is
also developing innovative interventions to address debilitating
conditions involving the sympathetic nervous system, such as
cardiac electrical storm, chronic pain, and spasticity. Pacira has
three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine
liposome injectable suspension), a long-acting local analgesic
currently approved for infiltration, fascial plane block, and as an
interscalene brachial plexus nerve block, an adductor canal nerve
block, and a sciatic nerve block in the popliteal fossa for
postsurgical pain management; ZILRETTA® (triamcinolone acetonide
extended-release injectable suspension), an extended-release,
intra-articular injection indicated for the management of
osteoarthritis knee pain; and ioveraº®, a novel, handheld device
for delivering immediate, long-acting, drug-free pain control using
precise, controlled doses of cold temperature to a targeted nerve.
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
indicated to produce postsurgical local analgesia via infiltration
in patients aged 6 years and older, and postsurgical regional
analgesia via an interscalene brachial plexus block in adults, a
sciatic nerve block in the popliteal fossa in adults, and an
adductor canal block in adults. The safety and effectiveness of
EXPAREL have not been established to produce postsurgical regional
analgesia via other nerve blocks besides an interscalene brachial
plexus nerve block, a sciatic nerve block in the popliteal fossa,
or an adductor canal block. The product combines bupivacaine with
multivesicular liposomes, 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 multivesicular liposome platform, a single dose of EXPAREL
delivers bupivacaine over time, providing significant reductions in
cumulative pain scores with up to a 78 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 about EXPAREL for
Patients
EXPAREL should not be used in obstetrical paracervical block
anesthesia. In studies in adults where EXPAREL was injected into a
wound, the most common side effects were nausea, constipation, and
vomiting. In studies in adults where EXPAREL was injected near a
nerve, the most common side effects were nausea, fever, and
constipation. In the study where EXPAREL was given to children, the
most common side effects were nausea, vomiting, constipation, low
blood pressure, low number of red blood cells, muscle twitching,
blurred vision, itching, and rapid heartbeat. EXPAREL can cause a
temporary loss of feeling and/or loss of muscle movement. How much
and how long the loss of feeling and/or muscle movement depends on
where and how much of EXPAREL was injected and may last for up to 5
days. EXPAREL is not recommended to be used in patients younger
than 6 years old for injection into the wound, for patients younger
than 18 years old, for injection near a nerve, and/or in pregnant
women. Tell your health care provider if you or your child has
liver disease, since this may affect how the active ingredient
(bupivacaine) in EXPAREL is eliminated from the body. EXPAREL
should not be injected into the spine, joints, or veins. The active
ingredient in EXPAREL can affect the nervous system and the
cardiovascular system; may cause an allergic reaction; may cause
damage if injected into the joints; and can cause a rare blood
disorder.
Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com
Media Contact:
Amber Sears, (973) 254-3587
amber.sears@pacira.com
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