Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) have 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 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.