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FDA Rejects New Indication for Postsurgical Analgesia Drug Exparel (Bupivacaine)
Pacira Pharmaceuticals has announced the receipt of a complete response letter (CRL) from the FDA following a review of the company’s supplemental new drug application (sNDA) for the use of Exparel (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia.
Pacira plans to schedule an end-of-review meeting with the FDA’s Division of Anesthesia, Analgesia, and Addiction Products of the Center for Drug Evaluation and Research to discuss the contents of the CRL.
The sNDA was submitted in May 2014. In September, the FDA took issue with the company’s promotion of Exparel. In a warning letter, the agency referred to educational technique flashcards and a journal advertisement that created the impression that Exparel had been approved for “new uses for which it lacks approval.” The promotional materials also overstated the drug’s efficacy for the purposes for which it had obtained approval, the agency’s warning letter said.
Exparel is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam technology, which delivers medication over a desired period.
Exparel is the only multivesicular liposome local anesthetic that can be used in either the peri- or postsurgical setting. According to Pacira, the product provided significant reductions in cumulative pain scores with a 45% decrease in opioid consumption; the clinical benefit of the opioid reduction has not been demonstrated, however.
Sources: Pacira Pharmaceuticals; March 2, 2015; and FDA; September 22, 2014.