Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy
15 Février 2024 - 2:36PM
Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in
its commitment to non-opioid pain management and regenerative
health solutions, today announced the publication of its pivotal
Phase 3 study supporting the efficacy and safety of EXPAREL®
(bupivacaine liposome injectable suspension) as a single-dose
sciatic nerve block in the popliteal fossa in patients undergoing
bunionectomy. The results demonstrate that EXPAREL significantly
improved pain control and reduced opioid consumption through 96
hours versus bupivacaine HCl. The data, which provided the basis
for FDA approval for this indication was published in the Journal
of Clinical Anesthesia.
“This data provides unequivocal evidence of the safety and
efficacy of EXPAREL as the first and only single-dose product to
safely provide four days of superior non-opioid pain control
compared to bupivacaine HCl,” said Frank D. Lee, Chief Executive
Officer of Pacira BioSciences. “Importantly, the use of EXPAREL as
a sciatic nerve block in the popliteal fossa affords clinicians
additional flexibility in their opioid-sparing pain management
approaches for foot and ankle procedures, which continue to migrate
to the outpatient environment where success is predicated on the
ability to provide appropriate pain control without the need for a
significant opioid burden.”
Key findings for EXPAREL 133 mg versus bupivacaine HCl 50 mg
administered as a single-dose sciatic nerve block in the popliteal
fossa for patients undergoing bunionectomy demonstrated
statistically significant and superior pain control over
bupivacaine for 4 days post-surgery:
- There was a 44% difference in pain scores
through 96 hours—the study’s primary endpoint—as measured by the
area under the curve, or AUC, of the Numerical Rating Scale pain
intensity scores from 0 to 96 hours post-surgery; P<0.00001
- Patients receiving EXPAREL consumed 61% fewer
opioids through 96 hours—the study’s secondary
endpoint—LSM total opioid consumption; P<0.00001
- Almost one quarter of patients in the EXPAREL
group needed no rescue opioids through 96 hours compared to the
bupivacaine group (24.4% vs 6% of patients, respectively)
- Additionally, patients in the EXPAREL 133 mg arm had
approximately five-fold higher odds of being opioid-free compared
with the bupivacaine HCl 50 mg arm; P=0.0003
The safety profiles of EXPAREL 133 mg and bupivacaine HCl 50 mg
were similar, with a similar proportion of adverse events (AEs) and
serious adverse events (SAEs), and all AEs were mild to moderate in
severity.
“The role of EXPAREL as a sciatic nerve block in the popliteal
fossa, particularly for pain control following foot and ankle
procedures, is pivotal as clinical goals toward outpatient
migration continue to grow,” said Gary Schwartz, MD, FASA, Vice
Chair of Pain and Anesthesiology at Maimonides Medical Center and
lead author on the publication. “The ability to deliver four days
of pain control and reduce reliance on opioids with a
single-administration—eliminating the burden of cumbersome
catheters and pumps—provides not only a valuable addition to the
pain management armamentarium, but also an opportunity to improve
patient satisfaction and outcomes for same-day surgical
procedures.”
About the Phase 3 Study of EXPAREL as a Sciatic Nerve
Block in the Popliteal FossaThe 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.
About Pacira BioSciences 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 analgesia currently approved 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
PatientsEXPAREL 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:
Sara Marino, (973) 248-7005
Sara.marino@pacira.com
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