FDA expands Exparel's approval — 4 insights

The FDA approved a supplemental new drug application for Pacira Pharmaceuticals' Exparel.

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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