Outpatient Surgery Magazine

Manager's Guide to Surgery's Ambulatory Anesthesia - July 2015

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

Issue link: http://outpatientsurgery.uberflip.com/i/538156

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Page 6 of 68

J U LY 2 0 1 5 O U T P A T I E N TS U R G E R Y. N E T 7 there should be a difference," says orthopedic surgeon William Schroer, MD, of the St. Louis Joint Replacement Institute. If true, then surgical facilities may have been paying too much for pain relief and patients may have experienced more post-op pain than necessary once they've been discharged home. Three years after Exparel entered the surgical market with a big splash, there's ample reason to doubt that it's added significantly to the pain-control armamentarium. In the surgical community, the drug has its fans, but doubts are growing. And federal government agencies like the FDA and the Department of Justice are taking a hard look at whether Pacira, the drug's maker, promoted the drug appropriately. A promising idea Exparel was born in the labs of Skyepharma, an English pharmaceutical maker specializing in novel drug delivery systems. In 2006, Skyepharma spun off the business unit in charge of SKY 042 and Pacira, a new pharmaceutical company, was born. In the prospectus for the company's public offering in 2010, officials wrote: "We believe Exparel will address a significant unmet ... need for a long-acting non-opioid postsurgical analgesic, resulting in simplified postsurgical pain man- agement and reduced opioid consumption. ... We estimate there are approxi- mately 24 million surgical procedures performed annually in the United States where Exparel could be used." Undoubtedly the principals truly believed SKY 042 would improve post-opera- tive pain control. But early Phase 2 testing of the drug against straight bupiva- caine, a drug that had been on the market for more than 2 decades, produced results that could not have thrilled them. Early tests indicated that Exparel's advantage over bupivacaine was weak or even non-existent. A double-blind, active-control trial of 108 total knee patients, designed to fig-

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