Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company, announced results of two data presentations on the impact of Exparel (bupivacaine liposome injectable suspension) on postsurgical opioid requirements in patients undergoing hysterectomy or mastectomy. The data were presented during two poster sessions at the annual meeting of the International Anaesthesia Research Society (IARS), being held in Honolulu March 21st-24th.
The first study compared the efficacy of Exparel to bupivacaine HCl when infiltrated into the transversus abdominis plane (TAP) to provide postsurgical analgesia following robotic assisted hysterectomy in 60 women. Blinded assessments of pain intensity, opioid intake and incidence of adverse events were taken for up to 72 hours after the procedure.
In comparison to the bupivacaine HCl treatment group, patients who received TAP infiltration with Exparel had: Significantly decreased total opioid intake in first 72 hours (by 57%); Significantly decreased incidence of nausea and vomiting in the first 72 hours (by 32%); Significantly lower maximal pain intensity at all time points (0-24 hours, 24-48 hours and 48-72 hours)
“Opioid use in patients undergoing abdominal surgeries can be particularly challenging, as their surgical intervention already increases the risk for gastrointestinal complications such as constipation and ileus, which we know opioids can exacerbate,” said Jacob Hutchins, M.D., Minnesota anaesthesiologist and the study’s lead investigator. “TAP infiltration provides highly effective incisional pain control, but the limited duration of traditional local anaesthetics, such as bupivacaine HCl, still requires a heavy reliance on opioids. Our research found that the benefits of TAP infiltration can be further amplified by using Exparel, which provides pain control that more closely matches the time course of the most severe postsurgical pain, thus reducing opioid use and associated adverse events.”
The IARS annual meeting also featured a case review assessing the impact of Exparel on postsurgical opioid consumption in a mastectomy patient with several risk factors, including morbid obesity, chronic obstructive pulmonary disease (COPD) with a greater than 40 pack-year history of smoking, and a history of opioid induced nausea and vomiting, all of which increase the risk of serious opioid-related complications. In the case study, the patient underwent radical mastectomy with axillary lymph node dissection and had Exparel infiltrated into the wound prior to skin closure. The case outcome, presented by Dennis Feierman, M.D., Vice Chairman in the Division of Anaesthesiology at Maimonides Medical Center in Brooklyn, NY, found that the patient’s highest pain score in the hospital was a two on a scale of 0-10, and that the patient did not receive any opioids or additional pain medications during her stay or at home. In addition, the patient did not complain of nausea or experience postsurgical vomiting.
“Minimizing the opioid burden on patients in the postsurgical setting is integral to breaking the cycle of opioid overuse, chronic use and abuse, all of which fuel the national opioid epidemic,” said Dave Stack, president, chief executive officer, chairman and director of Pacira. “The two studies presented at this year’s IARS annual meeting reinforce that Exparel can have a measurable impact on reducing or eliminating the use of opioids, and should play a vital role in opioid-sparing postsurgical pain management protocols.”
More than 70 million patients per year receive opioids in a hospital or clinic following surgery, and approximately one out of every 15 surgery patients in the United States will become long-term opioid users.
Exparel is currently 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 anaesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of Exparel delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 per cent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated.
Pacira Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients.