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Phase IV Study Evaluates Exparel (Bupivacaine) in Postsurgical Pain Management
On October 8, Pacira Pharmaceuticals, Inc., based in Parsippany, N.J., announced results from the first completed study in its prospective phase IV clinical program. The study was designed to compare the difference in three primary endpoints — cost, opioid consumption, and hospital length of stay (LOS) — between one group of patients receiving a standard opioid-based postsurgical pain-management regimen and a second group receiving Exparel (bupivacaine liposome injectable suspension) as the foundation of an opioid-sparing multimodal regimen.
The Exparel-based regimen achieved a statistically significant reduction in each primary endpoint, including a 60% reduction in hospital LOS in patients undergoing open colectomy.
Exparel is a non-opioid local analgesic indicated for administration into the surgical site to produce postsurgical analgesia.
In a previous soft-tissue trial, Exparel demonstrated a 30% reduction in pain and a 45% reduction in opioid use through 72 hours following excisional hemorrhoidectomy.
In the new phase IV, prospective, open-label IMPROVE study, 18 patients were enrolled in the opioid-based group, and 21 patients were enrolled in the Exparel-based multimodal-regimen group. Data from the study are being submitted for publication.
Exparel is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a product-delivery system that delivers medication over a desired period. Exparel is the only multivesicular liposome local anesthetic that can be used in the peri- or postsurgical setting in the same fashion as current local anesthetics. 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 under way to further demonstrate the drug’s safety and efficacy in other procedures.
For more information, visit the Pacira Pharmaceuticals Web site.