Parsippany, N.J. November 13, 2012 – Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the first data presentation supporting the use of EXPAREL® (bupivacaine liposome injectable suspension) infiltrated into the transversus abdominis plane (TAP) for postsurgical pain management. TAP infiltration is being increasingly utilized for postsurgical analgesia in abdominal procedures as clinicians aim to maintain pain control while reducing reliance on opioid analgesics. Andrew Sternlicht, M.D., Assistant Clinical Professor of Anesthesiology at the Tufts University School of Medicine, is lead author on a poster presentation of the data, which will be presented at the 11th Annual American Society of Regional Anesthesia and Pain Medicine (ASRA) Meeting, taking place November 15-18, 2012 in Miami.
Twenty-four patients undergoing robotic prostatectomy were enrolled in this open-label, prospective study to evaluate the efficacy and safety of EXPAREL via TAP infiltration. Key findings include:
• Patients required a mean of less than one oxycodone/acetaminophen tablet per day from their discharge until their day 10 visit.
• 100 percent of the available subjects reported being either satisfied or extremely satisfied with their postsurgical pain control at hospital discharge, at 72 hours and on day 10.
• When retrospectively compared to a 2011 study of patients who received a TAP infiltration of bupivacaine HCl, patients administered EXPAREL in the same fashion had similar or better pain scores with a reduced requirement for opioids.
There were no treatment-related adverse events in the study. EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
New Options are Imperative for Improved Postsurgical Analgesia
Additionally at ASRA, Tong-Joo Gan, M.D., M.H.S., Professor and Vice Chair, Department of Anesthesiology at Duke University Medical Center, will present a poster that describes results from a 300-patient survey conducted to assess the current state of postsurgical pain management.
Findings indicate that inadequately controlled postsurgical pain is ubiquitous:
• More than 85 percent of the patients surveyed reported experiencing postsurgical pain.
• Seventy-five percent of patients reporting pain characterized it as moderate, severe or extreme.
• Seventy-nine percent of patients reported experiencing side effects from pain medications, with the majority of those side effects appearing to be opioid-related.
Overall, the researchers found that postsurgical pain remains undermanaged; greater clinical adoption of multimodal therapy and novel non-opioid analgesics could potentially minimize opioid-related side effects and improve postsurgical pain management.
Both studies were supported by Pacira Pharmaceuticals.
The American Society of Regional Anesthesia and Pain Medicine (ASRA) is the largest subspecialty society in anesthesiology, addressing both the clinical needs of its physician community as well as striving to ensure excellence in patient care utilizing regional anesthesia and pain medicine.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at http://www.pacira.com.
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.
Pacira Pharmaceuticals, Inc.
James S. Scibetta, (973) 254-3570
Pure Communications, Inc.
Susan Heins, (864) 286-9597