Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved EXPAREL" data-scaytid="3">EXPAREL(TM) (bupivacaine" data-scaytid="5">bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia.
In a pivotal hemorrhoidectomy trial of Exparel compared to placebo, where all patients with inadequate pain control received opioids for rescue pain relief, EXPAREL demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours.
"As a non-opioid local analgesic, Exparel represents an evolution in the management of postsurgical pain by providing analgesia for several days with a single intraoperative infiltration," said Dave Stack, president and CEO of Pacira Pharmaceuticals, Inc. "This FDA approval is an important milestone for Pacira, as well as the millions of patients undergoing surgical procedures in the U.S. each year. We are excited to launch Exparel in the United States."
Exparel is an innovative product that combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. By utilizing the DepoFoam platform, a single dose of Exparel delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours. 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, which provide a relatively short duration of efficacy.
"The inability to effectively manage postsurgical pain is a challenge anesthesiologists and surgeons deal with on a daily basis," said Harold Minkowitz, MD, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas. "Typically, the first 48 to 72 hours after surgery are the most difficult from a pain management perspective, so a product like Exparel, which can provide pain relief with reduced opioid consumption for up to 72 hours, represents a significant, much-needed addition to the currently available postsurgical pain management options."
"This approval is welcome news for surgeons, for whom patient safety, comfort and satisfaction are of primary importance," said Sonia Ramamoorthy, MD, associate professor of surgery, University of California, San Diego. "Traditional opioid medications, while effective at providing pain relief, have a long list of unwanted side effects. Exparel, a single dose administration, non-opioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures."
Important Safety Information
The safety of Exparel has been evaluated in 21 clinical trials, which include over 1300 subjects in the safety database. Exparel administered locally into the surgical site was evaluated in 10 randomized, double-blind, clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of Exparel. Exparel is contraindicated in obstetrical paracervical block anesthesia. Other formulations of bupivacaine should not be administered within 96 hours following administration of Exparel. In these studies, the most common adverse reactions (incidence >10%) following Exparel administration were nausea, constipation, and vomiting.