FDA rejects Pacira's application for expanded use of pain drug

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[March 02, 2015]  (Reuters) - The U.S. Food and Drug Administration rejected Pacira Pharmaceuticals Inc's application for expanding the use of its post-surgery pain drug, Exparel.

Exparel is currently injected into the site of an operation to manage pain after surgery and Pacira sought to use the drug as a nerve numbing injection for cases where it is difficult to inject a painkiller directly into the affected area.

Pacira said on Monday it would work with the FDA to secure the new indication for Exparel, which will allow it to harness a wider range of post-operative patients.

The drug combines a local anesthetic, bupivacaine, with the company's DepoFoam technology, a drug delivery system that releases the medicine over a period of time.

Exparel, approved in April 2012 for post-surgical pain, generated $188.5 million of Pacira's nearly $197.6 million in revenue for the year ended Dec. 31.

Last week, Pacira had said it expected Exparel sales to rise to $310-$330 million in 2015, with about 10 percent of the projected revenue coming from the expanded use of the drug.

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(Reporting by Amrutha Penumudi in Bengaluru; Editing by Savio D'Souza)

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