Pacira Pharmaceuticals, Inc. Announces Additional Data Supporting Safety of EXPAREL® in Peripheral Nerve Block
-- Analysis Presented at the 2014 Annual Meeting of the
“Our review of this peripheral nerve block clinical program found that
EXPAREL administered at doses up to 266 mg as a femoral, intercostal or
ankle block exhibited a similar safety profile to both placebo and
bupivacaine HCl,” said
The comparative analysis found that all groups experienced a similar rate of adverse events (AEs) — 76% for EXPAREL vs 76% for placebo vs 61% for bupivacaine HCl — and that these appeared to be related to the procedure or opioid rescue rather than the study medication itself. The most common events were in the gastrointestinal disorders class, followed by general disorders/administration site conditions and nervous system disorders.
Additionally, the EXPAREL and placebo groups experienced a similar incidence of:
- Serious AEs (8% for EXPAREL vs 10% for placebo); none of these were assessed as being related to the study drug
- Nervous system AEs (21% in both groups)
- Cardiac AEs (9% vs 12%, respectively)
Older patients and patients with more co-morbidities were more prone to experience adverse events, as expected, and this trend was true across all groups.
“Building on the solid foundation of EXPAREL data that formed the basis
of our sNDA for an expanded nerve block indication, we are pleased to
announce that the first comprehensive review of our peripheral nerve
block program reinforces the safety profile of the product,” added
EXPAREL is indicated for single-dose administration into the surgical
site to produce postsurgical analgesia. Pacira has submitted a
supplemental New Drug Application (sNDA) to the
About Pacira
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 analgesia with reduced opioid requirements for up to 72 hours. 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 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 plans and
expectations regarding EXPAREL, and other statements containing the
words “believes,” “anticipates,” “plans,” “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: our ability to adequately resolve the issues raised in the
FDA’s warning letter; our and Patheon’s ability to successfully and
timely construct dedicated EXPAREL manufacturing suites; 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 for nerve block and the related timing and success of an sNDA;
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;
and other factors discussed in the “Risk Factors” of our most recent
Annual Report on Form 10-K for the fiscal year ended
Source:
Pacira Pharmaceuticals, Inc.
Company Contact:
Jessica Cho,
973-254-3574
Jessica.Cho@pacira.com
or
Media
Contact:
Pure Communications, Inc.
Susan Heins, 864-286-9597
sjheins@purecommunicationsinc.com