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Pacira receives supplemental NDA approval for Exparel
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Pacira Pharmaceuticals Inc. announced it has received FDA approval for its supplemental new drug application to broaden the use of Exparel, a bupivacaine liposome injectable suspension, to include administration via interscalene brachial plexus block to produce post-surgical regional analgesia.
According to a company press release, this approval makes bupivacaine liposome injectable suspension the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.
In a phase 3 study of 156 patients randomly assigned to receive either bupivacaine liposome injectable suspension combined with saline or placebo alone, the release noted results showed statistically significant cumulative pain scores in 48 hours for the group that received the bupivacaine liposome injectable suspension. Total post-surgical opioid consumption through 48 hours, opioid-free subjects through 48 hours and time to first opioid rescue through 48 hours were also statistically significant in the bupivacaine liposome injectable suspension group, according to results. The release also noted bupivacaine liposome injectable suspension had a safety profile consistent with the previously reported safety profile for wound infiltration, as well as with the profile of bupivacaine when used as a brachial plexus nerve block.
“Brachial plexus blocks are emerging as a mainstay of post-surgical pain control for upper extremity procedures and are well positioned to comprise more than 60% of all regional nerve block procedures within the next 2 years,” Dave Stack, chairman and CEO at Pacira Pharmaceuticals, said in the release. “In line with our corporate mission, we are gratified to offer clinicians and patients another option for achieving long-lasting non-opioid pain control with Exparel, and to provide an increased ability to transition procedure commonly thought of as inpatient to the ambulatory setting.”
Reference:
http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2341466