FDA Wants More Info Before Approving Exparel for Post-Op Nerve Block

Pacira announced that the FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for the use of Exparel (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia.

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Exparel is already indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a product delivery technology that delivers medication over a desired time period. Exparel represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of Exparel delivers bupivacaine over time, providing reductions in cumulative pain scores with a 45% decrease in opioid consumption. The clinical benefit of the opioid reduction was not demonstrated.

For more information call (973) 254-3560 or visit Exparel.com.

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