Pacira Pharmaceuticals, Inc. today announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following a review of its supplemental New Drug Application (sNDA) for the use of Exparel (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia. Pacira will immediately schedule an End-of-Review meeting with the Division of Anesthesia, Analgesia and Addiction Products of the Center for Drug Evaluation and Research to discuss the contents of the CRL.

“We are reviewing the contents of the CRL and will work actively with the FDA to bring this important new indication to our core and growing business in infiltration,” said Dave Stack, president, chief executive officer and chairman of Pacira. “Prescribed opioids in the acute care, postsurgical setting lead to chronic use and abuse in approximately one out of every 15 surgery patients in the United States; we remain committed to providing patients with long-acting, non-opioid analgesic options, like Exparel, to treat their pain while minimizing the risk of opioid-related adverse events. We look forward to finding solutions to address this public healthcare problem together with the FDA.”

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