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FDA Set to Review New Long-Lasting Bupivacaine for Post-Op Pain
Agency has accepted Pacira Pharmaceuticals' New Drug Application for Exparel.
Published:December 15, 2010
A new, long-lasting version of bupivacaine designed to provide patients with several days worth of post-operative pain relief is about to be formally reviewed for safety and efficacy by the Food and Drug Administration.
Pacira Pharmaceuticals announced this week that the FDA has accepted its New Drug Application for Exparel, a long-lasting, non-opioid analgesic. The drug consists of bupivacaine encapsulated in DepoFoam, the company's proprietary technology that allows Exparel's analgesic effects to last much longer than the the standard 6 to 8 hours. According to Pacira's website, Exparel is designed to provide 72 hours of post-surgical, non-opioid pain relief.
Pacira completed Phase III studies of Exparel last year and submitted the New Drug Application to the FDA in September. The company says the agency expects to complete its review of Exparel's NDA by July 28, 2011.
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