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forced to admit that a
clinical study that
demonstrated that
Exparel significantly
reduced pain intensity
compared to placebo
for up to 24 hours also
demonstrated that
"there was minimal to
no difference between
Exparel and placebo
treatments on mean
pain intensity" between
24 and 72 hours after
Exparel was adminis-
tered.
The FDA also said
Pacira had subtly pro-
moted the use of
Exparel in surgical pro-
cedures other than
those for which the
drug has been shown to
be safe and effective.
The agency "is con-
cerned with Pacira's
suggestions, made in an
array of professionally-
directed promotional
materials … that
Four numbers have been used to express how long Exparel works — or doesn't
work.
96
Exparel's physician advocates often say that plasma levels of bupiva-
caine can remain in your system for up to 96 hours, or 4 days, and
that bupivacaine continues to be released from the liposome during that time.
"Not to say that patients will have pain relief for that long, but plasma levels of
bupivacaine can persist for up to 96 hours," says Peter Whang, MD, FACS, a
Pacira consultant who's an associate professor in the department of orthope-
dics and rehabilitation at the Yale University School of Medicine in New
Haven, Conn.
72
The FDA last September objected to Pacira Pharmaceuticals'
claims that Exparel provides pain control that lasts for up to 72
hours, about 10 times longer than standard bupivacaine. "Exparel is heavily
dependent on how you infiltrate it," says a Pacira consultant who spoke on
the condition of anonymity. "When you infiltrate straight bupivacaine, it
spreads. When you inject Exparel, it only works where you place it."
48
A little more than a year ago, Dr. Whang was quoted as saying, "We
can administer the bupivacaine immediately post-operatively and
can expect pain relief for up to 72 hours." When Outpatient Surgery asked Dr.
Whang last month how much pain relief you can reasonably expect from
Exparel, he scaled back on his estimate. "You can count on 48 hours of relief,"
he says.
24
This is the maximum number of hours the FDA says the drug works.
"Exparel demonstrates significant reduction in pain intensity scores
when compared to placebo for up to 24 hours," reads Exparel's amended
claim in resolution to a recent FDA warning letter. FDA reviewer Arthur Simone,
MD, PhD, points out that "the duration of Exparel's analgesic effect appears to
be no more than 24 hours and not longer than that of bupivacaine hydrochlo-
ride"
— Dan O'Connor
SLIDING SCALE
How Many Days?
