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.
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.