Two New Studies Support Use of EXPAREL via Infiltration Into the Transversus Abdominis Plane for Pos
May 6th 2013 4:20PM
Updated May 6th 2013 4:35PM
Two New Studies Support Use of EXPAREL via Infiltration Into the Transversus Abdominis Plane for Postsurgical Pain Control
Data Presented at Annual Meetings of Leading Regional Anesthesia Societies Demonstrate Analgesia for Up to 72 Hours and High Patient Satisfaction
PARSIPPANY, N.J.--(BUSINESS WIRE)-- Pacira Pharmaceuticals, Inc. (NAS: PCRX) today announced findings from two new studies supporting the use of EXPAREL® (bupivacaine liposome injectable suspension) infiltrated into the transversus abdominis plane for postsurgical pain management. Infiltration into the transversus abdominis plane (or iTAP) is being increasingly utilized for postsurgical analgesia during upper or lower abdominal procedures for up to 72 hours of postsurgical analgesia with a non-opioid, local anesthetic.
The first study, presented at the 2013 Annual Meeting of the International Anesthesia Research Society (IARS) in San Diego on Sunday, May 5,2013 evaluated the use of EXPAREL administered via iTAP for postsurgical pain control in 13 patients who underwent open abdominal hernia repair. A team of researchers led by Dennis E. Feierman, M.D., vice chairman in the Division of Anesthesiology at the Maimonides Medical Center in Brooklyn, N.Y. recorded pain scores and patient satisfaction following EXPAREL administration via iTAP. This study was supported by Pacira Pharmaceuticals, Inc.
Key findings include:
- Patients' pain was well-controlled through 72 hours (mean pain score was <3 out of 10 through 120 hours after surgery, where 10 represents the worst possible pain)
- Most patients reported being "satisfied" or "extremely satisfied" with pain control at discharge and postsurgical day 10 (mean score of 4.4 at discharge and 4.6 at postsurgical follow-up visit on a scale of 0-5, where 5 represents the highest possible satisfaction)
- No serious adverse events were reported in the study
"The consistent results we observed from this study support the safety and clinical value of EXPAREL. The prolonged pain relief and improved patient satisfaction we observed using EXPAREL in TAP infiltration after large and generally painful umbilical hernia repairs was unprecedented," said Mark Kronenfeld, M.D., Vice Chairman of Anesthesiology and Medical Director of Perioperative Services at Maimonides Medical Center in Brooklyn, N.Y. and co- principal investigator on this research. "We are excited by the results, which support our Medical Center's goal of an opioid-sparing postoperative patient experience to avoid the often adverse side effects associated with the use of opioids."
The second study, a retrospective review of 20 patients undergoing hand-assisted nephrectomies and colorectal procedures and receiving an iTAP with EXPAREL for postsurgical pain control, was discussed during a poster presentation held on Saturday, May 4, 2013 at the 38th annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) in Boston.
Key findings include:
- Patients experienced minimal pain through 72 hours (mean pain score at rest of 2.3 or lower through 72 hours)
- Patients reported numbness at their incision site lasting between 48 to 72 hours postsurgically
- There were no treatment-related adverse events in the study
"Infiltration into the transversus abdominis plane using traditional local anesthetics is a highly-effective technique to produce regional pain control during surgery, but the postsurgical benefits rarely extend beyond 18 hours," said Jacob Hutchins, M.D., the study's lead investigator and Director of Perioperative and Interventional Pain Service in the Department of Anesthesiology at the University of Minnesota. "Based on this retrospective review, we're pleased to report that using EXPAREL in a TAP infiltration was shown to be a safe and effective option to extend postsurgical pain control for up to three days, when postsurgical pain is at its worst."
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. Since EXPAREL is used in a peri- or postsurgical setting in the same fashion as current local anesthetics, it has broad applications across a wide variety of surgical specialties ranging from general and colorectal surgery to bariatric and plastic surgery procedures.
Pacira Pharmaceuticals, Inc. (NAS: 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 www.pacira.com.
About EXPAREL ®
EXPAREL (bupivacaine liposome injectable suspension) is 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 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 http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3570
Pure Communications, Inc.
Susan Heins, 864-286-9597
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