Lotus Clinical Research worked closely with Pacira on this successful pivotal Phase 3 trial in total knee arthroplasty (TKA), providing scientific consulting and conducting the study within our CRO and the ERG site network. ERG-Lotus was able enroll this study far more rapidly than a typical TKA study, while employing a relatively small number of centers. Reducing the number of sites used in a study may decrease data variability and enhance the likelihood of positive study results1. ERG-Lotus has pioneered active recruitment techniques to bring knee replacement recruitment in line with established fast-enrolling acute postoperative pain models like bunionectomy and abdominoplasty.
1) Decreasing the number of clinical centers involved in an analgesic trial may increase effect size and reduce the probability of a false negative: Poster Presented at the American Pain Society (APS) 31th Annual Scientific Meeting held May 16-19, 2012 in Honolulu, Hawaii.
TAMPA, Fla., Sept. 07, 2022 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced positive topline results from its Phase 3 study of EXPAREL as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty. EXPAREL achieved the study’s primary endpoint demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.01). EXPAREL also achieved a statistically significant reduction in postsurgical opioid consumption through 96 hours (p<0.01) compared with bupivacaine HCl, a key secondary endpoint. EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.
With these positive results, Pacira plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration early next year seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal.
“These positive data build on our market-leading position in long-lasting, non-opioid pain control by establishing EXPAREL as the first and only product with positive Phase 3 data safely demonstrating four days of superior postsurgical pain relief compared to bupivacaine,” said Dave Stack, chairman and chief executive officer of Pacira BioSciences. “We believe we are now well positioned to broaden the EXPAREL label with an additional nerve block indication and further solidify the role of EXPAREL as a cornerstone in opioid-sparing postsurgical pain management regimens that support accelerated recovery and increased case migration to the 23-hour stay environment. This will help us continue to drive paradigm changes in patient care as we redefine the role of opioids as a last resort rescue medication.”
The Phase 3, randomized, double-blind, multicenter, active-controlled study was designed to evaluate the efficacy, safety, and pharmacokinetics of EXPAREL admixed with bupivacaine HCl versus bupivacaine HCl administered as a femoral nerve block in the adductor canal block for postsurgical analgesia in subjects undergoing primary unilateral total knee arthroplasty. In total, 166 subjects were randomized 1:1 to receive either 10 mL (133 mg) of EXPAREL admixed with 10 mL (50 mg) 0.5% bupivacaine HCl or 10 mL (50 mg) 0.5% of bupivacaine HCl mixed with 10 mL normal saline.
The study’s primary endpoint was the area under the curve, or AUC, of the Numerical Rating Scale pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.5% bupivacaine HCl. Secondary endpoints included total postsurgical opioid consumption from 0 to 96 hours comparing EXPAREL to bupivacaine HCl.
Pacira plans to submit the full results from the Phase 3 study for presentation at future scientific conferences and for publication in a peer-reviewed journal.