NEW YORK, April 12, 2013 – Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced results from EXCLAIM, its Phase 4 prospective, observational study to assess the use of EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical analgesia in patients undergoing four common plastic surgery procedures. Patients who received EXPAREL following abdominoplasty, breast augmentation, breast reduction or a combination abdominoplasty/breast procedure reported low pain scores, high satisfaction with pain control and minimal opioid use. The findings were presented today during the Hot Topics session of The Aesthetic Meeting 2013, the 46th annual meeting of the American Society for Aesthetic Plastic Surgery (ASAPS).
“When considering an elective procedure, postsurgical pain ranks high on the list of patient concerns, and adequate pain management during the first few days after surgery—when pain is at its worst—is crucial to a patient’s overall satisfaction with the surgeon and the procedure,” said Stephan Finical, M.D., FACS, an EXCLAIM study investigator and practicing plastic surgeon in Charlotte, N.C. who presented the data at the Aesthetic Meeting. “Based on our findings, use of EXPAREL helps to effectively manage pain during the critically important 72 hours after surgery while reducing the need for opioid medications, which can result in a host of unwanted side effects.”
The EXCLAIM study encompassed a total of 49 patients evaluated from 10 sites nationwide. In the immediate postsurgical setting and for three days following their procedure, patients were asked to rate their pain intensity and satisfaction with pain management, as well as report the number of opioids taken as rescue medication and the impact any associated opioid-related adverse events had on their quality of life.
Key findings demonstrated that patients treated with EXPAREL reported:
• Low pain scores (mean score of =4.0 on pain intensity scale of 0-10)
• Minimal opioid use for rescue pain relief (mean of <3 tablets taken daily vs historically expected 10 tablets per day in a typical postsurgical pain management paradigm)
• High satisfaction with pain management (all patients reported =3.0 on a 0-4 scale)
• Excellent overall benefit of analgesia (OBAS) achieved with EXPAREL (mean score of =5 out of a possible 28 points). The OBAS is a validated tool to measure patients’ benefit from their postsurgical pain therapy inclusive of pain relief, satisfaction and distress from opioid-related adverse events. Low OBAS scores indicate a high overall benefit of analgesia.
“Apprehension about postsurgical pain can make patients hesitant to proceed with cosmetic plastic surgery, especially when considering procedures such as abdominoplasty that are often thought of as being associated with significant discomfort and downtime after surgery,” added Kevin L. Smith, M.D., FACS, and a second EXCLAIM trial investigator who also practices in Charlotte, N.C. “The positive patient-reported pain, satisfaction and quality of life scores we recorded suggest the important role EXPAREL could play as the foundation of a postsurgical pain management plan in cosmetic procedures.”
EXPAREL is the first and only single-dose local analgesic that provides pain control with reduced opioid requirements for up to 72 hours. It was approved for administration into the surgical site to produce postsurgical analgesia by the U.S. Food and Drug Administration in 2011. 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.
The study findings will be presented at the Hot Topics session of the Aesthetic Meeting 2013 on Friday, April 12th at 11:34 a.m. ET at the New York Marriott Marquis. For more information, please visit http://www.surgery.org/downloads/microsite/meeting2013/index.php
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 www.pacira.com.
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