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-
