Archive Ambulatory Anesthesia 2015

Which Drug is Better For Post-op Pain Control?

Bupivacaine, at a price of about $2.80 per shot, or the liposomal bupivacaine formulation trade-named Exparel, at about $285 per vial? What we found may surprise you.

Dan O

Dan O'Connor, Editor-in-Chief

BIO

the price of pain control

Examining Exparel's Effectiveness

It sounds like a great concept. Encapsulate bupivacaine in tiny bubbles made out of the same material as a cell membrane, and inject it into the muscles and soft tissues around the surgical wound. Like soap bubbles in a dishpan, these bubbles will burst slowly and predictably, releasing the pain-numbing medication over 72 hours for up to 3 days of pain control. No pumps, no catheters, no opioids. That's the promise of Exparel. Many studies, however, have found no significant benefit from using liposomal bupivacaine instead of standard bupivacaine in periarticular injections as part of a multimodal pain management strategy.

When attempting to control post-operative pain, which drug is better — bupivacaine, at a price of about $2.80 per vial, or the liposomal bupivacaine formulation trade-named Exparel, at about $285 per vial?

For the price, Exparel should be lights-out better. But it's not clear if Pacira Pharmaceuticals' flagship pain medication is even slightly superior at controlling post-op pain than conventional local anesthetics. An examination of Exparel's clinical trial data, the FDA's evaluation of those data and a patchwork of post-approval studies show very little difference between the performance of liposomal bupivacaine and standard bupivacaine.

"And at $285 for a dose of Exparel versus $2.80 for a shot of bupivacaine, 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 management and reduced opioid consumption. ... We estimate there are approximately 24 million surgical procedures performed annually in the United States where Exparel could be used."

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