The pharmaceutical company previously submitted an application seeking to use the local anesthetic as a regional pain-killer.
The committee’s feedback doesn’t necessarily mean the immediate end for Pacira’s pitch – the FDA will take the vote into consideration as it makes a final decision for the expanded indication.
“We remain confident that the data from our clinical program provides all of the necessary information to support expansion of the current Exparel label for infiltration to also include use as a nerve block for regional analgesia,” Pacira’s chairman & CEO, Dave Stack said in prepared remarks.
“We look forward to working with the FDA to address any outstanding questions as we move through the sNDA review process toward our ultimate goal of offering additional flexibility in the way Exparel can be administered so that clinicians and patients alike have increased opportunity to realize the benefits of long-lasting non-opioid pain control.”
PCRX shares were trading at $30.60 apiece in mid-afternoon activity today, down -15.2%.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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