Exparel Ph III trial in intercostal nerve block fails to meet primary endpoint

USA-based Pacira Pharmaceuticals (Nasdaq: PCRX) has reported results from its second pivotal, Phase III clinical trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in intercostal nerve block for posterolateral thoracotomy showing that the drug did not achieve its primary endpoint of a reduction of cumulative pain scores over 72 hours.

The 180 patients in this randomized, double-blind study across the USA, Bulgaria, Georgia, Poland and the Czech Republic received either 266mg of Exparel or placebo. Patients recruited in Bulgaria and Georgia demonstrated a response favoring Exparel over placebo, but this response was less pronounced in patients in Poland and missing in patients recruited in the Czech Republic (there were too few US patients in the study to be meaningful). 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 2013, Pacira reported positive findings from the Phase II portion of its other pivotal nerve block trial, a femoral nerve block study for total knee arthroplasty; the Phase III portion of this study is ongoing. The US Food and Drug Administration indicated to the company at its end-of-Phase II 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 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 (sNDA) anticipated in early 2014.