Pacira Pharmaceuticals Inc., 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, has announced that US Food and Drug Administration (FDA) has approved Exparel (bupivacaine liposome injectable suspension) 1.3 per cent 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.
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 anaesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anaesthetics, which provide a relatively short duration of efficacy.
"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 US each year. We are excited to launch Exparel in the United States."
"The inability to effectively manage postsurgical pain is a challenge anesthesiologists and surgeons deal with on a daily basis," said Harold Minkowitz, M.D., 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, M.D., 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."