Pacira Pharmaceuticals Announces Official Launch of EXPAREL to the Oral Surgeon Community to Treat Pain Following Oral and Maxillo-facial Procedures
New research presented at AAOMS 2016 shows EXPAREL is safe and effective for pain relief following removal of wisdom teeth
PARSIPPANY, N.J., Sept. 21, 2016 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced new data regarding the benefit of EXPAREL® (bupivacaine liposome injectable suspension) for patients undergoing third molar (wisdom teeth) extraction, marking the official launch of the product to the oral surgeon community. EXPAREL is a local analgesic that provides prolonged non-opioid postsurgical pain control.
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.
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 American Association of Oral and Maxillofacial Surgeons (AAOMS) in Las Vegas, Nevada. 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. When considering oral surgery procedures, especially third molar extraction, postsurgical pain often ranks among patients’ top concerns so the ability to ease anxiety and offer a non-opioid option that provides ample pain management during the first few days after surgery—when pain is often at its worst—is a real benefit to both clinicians and our patients, alike.
Comments: Exparel comprises the use of multivesicular liposomes which, because of their large size, reside at the injection site and slowly release the encapsulated water soluble drug.