FDA approves Exparel sNDA for postsurgical regional analgesia.- Pacira Pharma.

Pacira Pharmaceuticals, Inc. announced that the FDA has approved its supplemental new drug application (sNDA) to broaden the use of Exparel (bupivacaine liposome injectable suspension) to include administration via interscalene brachial plexus block to produce postsurgical regional analgesia. With this approval, Exparel is the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.

�Brachial plexus blocks are emerging as a mainstay of postsurgical pain control for upper extremity procedures, and are well positioned to comprise more than 60 percent of all regional nerve block procedures within the next two years, � said Dave Stack, chairman and chief executive officer at Pacira Pharmaceuticals. Since its initial approval in 2011 for single-dose infiltration into the surgical site, more than 3.75 million patients have been treated with Exparel in the post-marketing setting. The expansion of the Exparel label to now also include interscalene brachial plexus nerve block allows clinicians to potentially eliminate the need for cumbersome catheters and pumps traditionally used to extend the duration of regional analgesia.

�There is a critical need in the postsurgical setting for non-opioid options that turn off pain at the surgical site and reduce the need for opioids,� said Jeffrey Gadsden, MD, Chief of Orthopaedics, Plastics, and Regional Anesthesiology and Associate Professor of Anesthesiology at Duke University School of Medicine. �The ability to provide effective regional analgesia with a single dose of EXparel is a tremendous victory for patients and advances the imperative need for low- or no-opioid pain management strategies.�

The sNDA approval was based on positive data from a Phase 3 study of Exparel in brachial plexus block for shoulder surgeries, in which Exparel demonstrated statistical significance for the primary endpoint of cumulative pain scores over 48 hours as measured by the area under the curve (P<0.0001). exparel also achieved statistical significance versus placebo for the studys key secondary endpoints as follows: total postsurgical opioid consumption through 48 hours p><0.0001); opioid-free subjects through 48 hours p><0.01); and time to first opioid rescue through 48 hours p><0.0001). the safety profile for exparel in the interscalene brachial plexus nerve block study was consistent with the previously reported safety profile of exparel in wound infiltration and also with the profile of bupivacaine when used as a brachial plexus nerve block. the study randomized 156 patients across 17 sites in a 1:1 ratio to receive a single dose of either exparel 133 mg in 10 ml expanded in volume with 10 ml of normal saline for a total volume of 20 ml or placebo 20 ml. exparel was administered as a single-dose brachial plexus block under ultrasound guidance at least one hour prior to surgery. all patients were eligible to receive postsurgical rescue opioids upon request for pain control.>

Comment: The FDA has stated that today�s action helps to fulfill a need for additional nonaddictive pain management tools by providing a new option for certain patients that can last up to 72 hours following surgery; however, its new use is limited to individuals who will undergo shoulder surgeries. We are taking careful steps to make sure that health care professionals treating pain are armed with this important information about the product�s approved uses as well as its limitations in order to make the best pain management decisions for a patient�s unique needs.