Here’s what you should know.
1. The new approval allows Exparel to be administered through an interscalene brachial plexus product to produce regional analgesia.
2. Exparel is now the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries.
3. Exparel was initially approved in 2011 for single-dose infiltration into the surgical site. Since then, more than 3.75 million patients have been treated with Exparel.
4. The FDA based its approval off of a phase 3 study of Exparel. In the study, Exparel demonstrated its statistical significance concerning the primary endpoint of cumulative pain scores over a 48-hour period.
Pacira Pharmaceuticals Chairman and CEO Dave Stack said, “In line with our corporate mission, we are very gratified to offer [physicians] and patients another option for achieving long-lasting non-opioid pain control with Exparel, and to provide an increased ability to transition procedures commonly thought of as inpatient to the ambulatory setting.”
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