Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today 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.
“We are pleased with the interim analysis of the safety and efficacy of EXPAREL in this important orthopedic indication”
"We are pleased with the interim analysis of the safety and efficacy of EXPAREL in this important orthopedic indication," said Dave Stack, president and chief executive officer of Pacira. "Based on the independent Data Safety Monitoring Board analysis, we believe that a single-dose injection of EXPAREL as a femoral nerve block can provide several days of analgesia without significant motor blockade. We look forward to initiating the Phase 3 portion of this trial and ultimately to providing orthopedic patients with a new option that could significantly contribute to the management of their postsurgical pain by replacing a perineural catheter, drug reservoir and pump with a single-dose injection of EXPAREL."
Designed as a two-part study, the first part of this double-blind, placebo-controlled trial evaluated the safety and efficacy of three doses of EXPAREL in 100 total patients to identify a single therapeutic dose for further investigation. A total of 100 patients received a femoral nerve block prior to TKA of 67 mg, 133 mg or 266 mg of EXPAREL or placebo (25 patients per group). 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 the Phase 3 portion of the study, those 180 patients will receive either 266 mg of EXPAREL or placebo as a femoral nerve block (90 randomized to each arm). In addition to pharmacokinetic and safety data, multiple efficacy endpoints will be measured.
In addition, Pacira also reported today 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 Company expects that results from this additional Phase 3 study will contribute to a planned U.S. Food and Drug Administration supplemental New Drug Application (sNDA) submission anticipated for early 2014.
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