Pacira 'confident' data supports Exparel label expansion despite 4-6 panel vote
Pacira Pharmaceuticals announced that the U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee did not reach a unanimous decision on the efficacy and safety of the use of Exparel as a nerve block to produce regional analgesia. The committee's feedback will be considered by the FDA in its review of the company's sNDA seeking expansion of the Exparel label. The Prescription Drug User Fee Act, or PDUFA, date for completion of the review is April 6, 2018. Four committee members voted to recommend FDA approval of the Exparel sNDA while six believed that more research is needed to further support the proposed new 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. 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," said Dave Stack, chairman and CEO at Pacira.