|Pacira Pharmaceuticals Announces Completion of End-of-Review Process with FDA Regarding EXPAREL sNDA for Nerve Block|
Pacira requested an End-of-Review meeting in
Based upon the
Pacira anticipates working with the
“We are appreciative that the DAAAP staff and leadership engaged the
Pacira team in constructive dialogue regarding the development of
EXPAREL use in nerve block,” said
DepoFoam® Spray Manufacturing Process Update
Pacira requested a Type C meeting in
Based on this feedback, Pacira intends to pursue the manufacturing of DepoFoam-based products using the spray process.
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 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 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 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, outlook and prospects, including statements about expected
non-GAAP operating expenses, 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 use of EXPAREL to additional indications, including nerve
block, oral surgery and chronic pain, as well as pediatrics, and the
timing and success of any related clinical trials; the related timing
and success of a
Pacira Pharmaceuticals, Inc.