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|Pacira Pharmaceuticals, Inc. Announces Commercial Availability of EXPAREL®|
Strong pre-launch commercialization efforts including more than 40 data publications and more than 1,700 interactions with potential customers have laid the groundwork for what Pacira believes will be the successful introduction of EXPAREL into the hospital marketplace.
“For Pacira, today is the culmination of several important
organizational milestones that span the last several years, with the
most significant being the
The Pacira sales force, which consists of 63 hospital specialists who
cover more than 81 percent of the market Pacira is targeting for
EXPAREL, was launched in
“Through the work of our field force and the commercialization
activities executed to date, awareness and anticipated demand for
EXPAREL has continued to grow among our target markets,” said
EXPAREL® (bupivacaine liposome injectable suspension) is indicated for administration 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. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. 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 www.EXPAREL.com.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about EXPAREL's potential and
the expected timing of commercial launch, expected 2012 revenues 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: the success of our sales
and manufacturing efforts in support of the commercial launch 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 commercialization and marketing capabilities; and
other factors discussed in the "Risk Factors" section of our Annual
Report on Form 10-K for the fiscal year ended