PARSIPPANY, N.J.--(BUSINESS WIRE)--Feb. 11, 2015--
Pacira
Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced resolution of
matters pertaining to certain promotional aspects of EXPAREL detailed in
a recent Warning Letter from the U.S. Food and Drug Administration’s
(FDA) Office of Prescription Drug Promotion (OPDP). Pacira announced
receipt of the Warning Letter on September 25, 2014 and has since been
in constructive discussions with OPDP.
The resolution between Pacira and OPDP is summarized below. Pacira is
actively working to ensure that its sales force and other promotional
channels communicate these points to customers thoroughly and accurately:
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EXPAREL is broadly indicated for administration into the surgical site
to produce postsurgical analgesia. Approval was based on pivotal
trials conducted in excisional hemorrhoidectomy and bunionectomy
surgical models, and thus, the basis for assessment of safety and
efficacy was limited to those two procedures.
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Regarding duration of efficacy, in both pivotal trials, EXPAREL
demonstrated a significant reduction in pain intensity scores compared
to placebo for up to 24 hours. In the hemorrhoidectomy trial, which
had a primary endpoint of cumulative pain scores over the first 72
hours, there was minimal to no difference in pain intensity scores
between EXPAREL and placebo from 24 to 72 hours; however, there was a
cumulative decrease in opioid consumption through 72 hours. The
clinical benefit of that reduction was not demonstrated.
As per the FDA approval documents, in both clinical trials, the mean
pain intensity score for the placebo patients decreased to levels
similar to the EXPAREL patients. All patients had access to rescue
opioid medication to control pain as needed after surgery; in the
hemorrhoidectomy trial, 88 percent of patients in the placebo group had
rescued with opioids by 24 hours.
“We are pleased to have reached a mutually acceptable resolution with
the OPDP regarding the matters raised in the warning letter,” said Dave
Stack, president, chief executive officer and chairman of Pacira. “In
the face of our nation’s burgeoning opioid abuse epidemic, we continue
to believe that EXPAREL plays a critical role in reducing our reliance
on and overuse of opioids in the acute care setting by providing a
viable non-opioid alternative.”
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 current emphasis is the
development of non-opioid products for postsurgical pain control, and
its lead product, EXPAREL® (bupivacaine liposome injectable suspension),
was commercially launched in the United States in April 2012. EXPAREL
and two other products have utilized the Pacira proprietary product
delivery technology DepoFoam®, a unique platform that encapsulates drugs
without altering their molecular structure and then 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 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 in the same fashion as current local anesthetics. By utilizing
the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine
over time, providing significant reductions in cumulative pain scores
with a 45% 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.
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/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about our expected revenues,
and other statements containing the words “believes,” “anticipates,”
“plans,” “estimates,” “expects,” 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; the
size and growth of the potential markets for EXPAREL and our ability to
serve those markets; our plans to expand the indications of EXPAREL,
including nerve block, oral surgery, chronic pain or repeat
administration, pediatrics and the related timing and success of a
United States Food and Drug Administration supplemental New Drug
Application; the adverse effects and impacts of FDA warning letters; our
plans to evaluate, develop and pursue additional DepoFoam-based product
candidates; clinical studies 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, 2013, 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.

Source: Pacira Pharmaceuticals, Inc.
Company Contact:
Pacira Pharmaceuticals, Inc.
Jessica
Cho, 973-254-3574
or
Media Contact:
Pure
Communications, Inc.
Susan Heins, 864-286-9597