PCRX - Pacira stock falls 15% despite non-opioid pain drug Exparel meeting trial's goals

Pacira BioSciences ( NASDAQ: PCRX ) said its non-opioid drug Exparel met the main goal of a phase 3 trial by showing a statistically significant reduction in pain compared to anesthetic bupivacaine HCl, through 96 hours after a type of toe surgery.

The company was evaluating Exparel as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy — a surgical procedure to move the toes back to a correct position.

Exparel also saw statistical significance reduction in postsurgical opioid consumption and percentage of opioid-free patients through 96 hours, compared to bupivacaine HCl, which were key secondary goal, the company said in a Sept. 21 press release.

The study was conducted in two parts and in total, the study randomized 185 people.

"With the successful readout of our second Phase 3 study , we now have an overwhelmingly positive body of data supporting EXPAREL as the first and only single-dose product to safely demonstrate four days of superior pain control versus bupivacaine," said Pacira Chairman and CEO Dave Stack.

Pacira plans to submit an application to the U.S. Food and Drug Administration (FDA) in Q1 2023 seeking expanded approval of Exparel in sciatic nerve blocks in the popliteal fossa and femoral nerve blocks in the adductor canal.

PCRX -14.59% to 47 premarket Sept. 21

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