In 96 hours, the study’s major and important secondary endpoints—statistically substantial decreases in postsurgical pain and opioid consumption—were met.
Pacira BioSciences (NASDAQ:PCRX)
Pacira BioSciences (NASDAQ:PCRX), a company specializing in non-opioid pain management, said Wednesday that the primary endpoint of a Phase 3 trial for its top product, Exparel, had been met. This has enabled the business to pursue label expansion for the local anesthetic.
The randomized experiment compares the effectiveness of Exparel with bupivacaine HCl when given as a femoral nerve block in a person’s adductor canal and in patients having total knee arthroplasty.
In the multicenter experiment, 166 participants were randomly assigned to receive either Exparel mixed with the local anesthetic bupivacaine HCl or bupivacaine HCl mixed with ordinary saline.
Topline findings demonstrate that Exparel met the primary aim of the study by statistically significantly reducing overall pain scores from 0 to 96 hours when compared to bupivacaine HCl. The trial also met a crucial secondary aim by showing a statistically significant decrease in postsurgical opioid usage through 96 hours compared with bupivacaine HCl.
“We believe we are now in a good position to expand the EXPAREL label to include an additional indication for nerve blocks and further establish EXPAREL as a cornerstone in opioid-sparing postsurgical pain treatment regimens,” the company claims. Pacira’s CEO, Dave Stack, said in a statement.
To request a label expansion for Exparel to include the new indication, Pacira anticipates submitting a supplemental New Drug Application to the FDA early in the following year. The business has not yet submitted the data for publication in a peer-reviewed journal.
For the month of July 2022, Pacira reported initial unaudited net product sales of $50.2 million. COVID-19 and pandemic-related problems have had an impact on the company’s earnings, including the large postponement or suspension of the scheduling of elective surgical procedures as a result of government orders and public health guidelines. $506.5 million in A total of $506.5les from Exparel were reported by Pacira in 2021, representing a 23% YoY rise.
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