6:32AM Pacira Pharma announces positive interim analysis of EXPAREL in femoral nerve block for total knee arthroplasty (PCRX) 29.62 : Co announced findings from the completed first part of its Phase 2/3 clinical trial assessing the use and administration of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose injection femoral nerve block for total knee arthroplasty surgery (TKA). Results show safety and efficacy of EXPAREL in femoral nerve block to support initiation of the Phase 3 portion of the pivotal trial. Based on the evaluation of both safety and efficacy after 72 hours of follow-up, a single dose level was to be selected for assessment in the second part of the study. Following the review of the data, the committee responsible for assessing the safety and efficacy profile determined that EXPAREL should be dosed at 266 mg in the Phase 3 portion of the study, which will be initiated shortly. The committee also confirmed that if results from the Phase 2 portion of the trial are replicated in Phase 3, the target enrollment of 180 patients should be adequate to demonstrate the safety and efficacy of the indication.
In addition, co also reported that patient enrollment was completed in a second Phase 3 nerve block clinical trial. This double-blind, placebo-controlled intercostal nerve block study enrolled 180 patients (90 patients on each arm) who were undergoing thoracotomy. The co expects that results from this additional Phase 3 study will contribute to a planned FDA supplemental New Drug Application (sNDA) submission anticipated for early 2014.
