PCRX - Pacira stock pops on getting FDA review for pain drug Exparel's expanded label

2023-03-29 08:43:06 ET

The U.S. Food and Drug Administration (FDA) accepted to review Pacira BioSciences' ( NASDAQ: PCRX ) application seeking expanded label for non-opioid pain drug Exparel.

The company's supplemental new drug application (sNDA) is seeking Exparel's label to include both single-dose sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.

The FDA is expected to make a decision on the sNDA by Nov. 13.

The filing was backed by data from two phase 3 studies in which Exparel showed reductions in postsurgical pain and opioid consumption through 96 hours compared with bupivacaine HCl after surgery.

"We believe these positive datasets provide the basis for broadening the EXPAREL label to include both sciatic and femoral nerve blocks, which represents the opportunity to manage pain with a single 10 mL dose of EXPAREL for more than 3 million lower extremity procedures annually," said Pacira Chairman and CEO Dave Stack.

Exparel is currently approved for single-dose infiltration in patients six years and older, to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia, according to the company.

PCRX +4.99% to $41.90 premarket March 29

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