Pacira's Exparel Ph 3 Trial In Intercostal Nerve Block Fails To Meet Main Goal

(RTTNews) - Pacira Pharmaceuticals, Inc. (PCRX) its second pivotal, Phase 3 clinical trial assessing the safety and efficacy of Exparel in intercostal nerve block for posterolateral thoracotomy did not achieve its primary endpoint of a reduction of cumulative pain scores over 72 hours. The 180 patients in the randomized, double-blind study across the U.S., Bulgaria, Georgia, Poland and the Czech Republic received either 266 mg of Exparel or placebo. Patients recruited in Bulgaria and Georgia demonstrated a response favoring Exparel over placebo, but that response was less pronounced in patients in Poland and missing in patients recruited in the Czech Republic.

The complete data set from the trial will be available in the next few weeks, and further analyses are currently underway to better understand why patients in some countries had positive results while others had a very high placebo response.

In May, Pacira reported positive findings from the Phase 2 portion of its other pivotal nerve block trial, a femoral nerve block study for total knee arthroplasty; the Phase 3 portion of that study is ongoing. The U.S. Food and Drug Administration indicated to the company at its End-of-Phase 2 Meeting that a single pivotal trial meeting its primary endpoint would be sufficient to gain approval for the nerve block indication, assuming demonstration of adequate safety.

Pacira said it plans to submit data from the ongoing femoral nerve block study to demonstrate efficacy and safety, as well as safety data from the intercostal nerve block study, for a supplemental New Drug Application anticipated in early 2014.

Exparel is currently indicated for single-dose administration into the surgical site to produce postsurgical analgesia.