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Pacira Pharmaceuticals Announces Official Launch of EXPAREL to the Oral Surgeon Community to Treat Pain Following Oral and Maxillofacial Procedures
As the nation battles the opioid addiction crisis, there is a particular opportunity to offer opioid alternatives to treat postsurgical pain in oral surgery patients. A recent study published in the
“We are pleased to work with the oral surgery community to help make EXPAREL available to patients undergoing third molar extraction and other relevant oral and maxillofacial procedures where long-lasting pain control is required to help patients get through the immediate postsurgical period,” said
The formal launch of EXPAREL to the oral surgeon community coincides with the presentation of new data on the safety and efficacy of the product in this patient population, which is occurring this week at the annual meeting of the
The data were generated from a prospective, randomized, double-blind, placebo-controlled study during which patients having all four wisdom teeth removed were randomized to receive a lidocaine nerve block followed by infiltration with either EXPAREL 133 mg (10 mL; 59 subjects) or placebo (10 mL saline; 30 subjects). A total of 166 subjects were enrolled in the study; 77 subjects were excluded due to protocol deviations.
Patients receiving EXPAREL demonstrated a numerically lower overall mean opioid consumption compared to patients administered placebo. Other key findings included:
- Significantly lower pain scores at 48 hours (P=0.0226), the primary endpoint of the study. Pain scores were also significantly lower compared to placebo at 24 hours (P=0.0192), 72 hours (P=0.0469), and 96 hours (P=0.0450).
- No difference in adverse event rates between the EXPAREL and placebo groups were observed; treatment-emergent adverse events were mild or moderate.
“This preliminary study data provides encouraging support for both the strong safety profile of EXPAREL and its potential to deliver prolonged pain management following oral surgery,” said
The study, titled Analgesic Efficacy and Safety of EXPAREL® (bupivacaine liposome injectable suspension) in Subjects Undergoing Third Molar Surgery: Preliminary Results of a Randomized Controlled Study, will be presented from the podium on
Other EXPAREL-related events at AAOMS include:
- New Ways of Managing Pain in Your Oral and Maxillofacial Patients, a Pacira-sponsored Learning Expo
Wednesday, September 21, 2016
4:30 PM-6:00 PM PDT
- Place: Mandalay Bay Ballroom L
- Setting New Expectations for Pain Management, a Pacira-sponsored program
Thursday, September 22, 2016
12:00 PM-1:00 PM PDT
- Place: Mandalay Bay Convention Center Exhibit Hall (1200 Aisle)
EXPAREL is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in patients 18 years of age and older.
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.
Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” 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 and opportunities, and the timing and success of any related clinical trials; the related timing and success of
Pacira Pharmaceuticals, Inc. Amber Sears(973) 254-3587 firstname.lastname@example.org Media Contact: Coyne Public Relations Alyssa Schneider, (973) 588-2270 email@example.com