ARTICLE | Clinical News

Exparel: Additional Phase III data

April 28, 2014 7:00 AM UTC

Additional data from a 2-part, double-blind, U.S. Phase II/III trial in 278 patients undergoing total knee arthroplasty showed that a single femoral nerve blocking administration of Exparel met the secondary endpoint of a greater proportion of patients who were pain-free at 60 hours vs. placebo (50% vs. 40%, p<0.05). Additionally, total opioid use was 24% lower in patients receiving Exparel vs. placebo (p<0.05). Furthermore, a greater proportion of patients receiving Exparel were "extremely satisfied" with their pain control at day 7 (55% vs. 43%) and at day 30 (65% vs. 50%) vs. placebo. There was no significant difference between treatment groups in the time to first opioid rescue. Patients were offered rescue narcotics as needed. Data were presented at the American Society of Regional Anesthesia and Pain Medicine meeting in Chicago. In February, Pacira reported that Exparel met the primary endpoint of reducing cumulative pain intensity scores through 72 hours vs. placebo (p<0.0001) (see BioCentury, March 3). ...