Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced results from its second pivotal, Phase 3 clinical trial assessing the safety and efficacy of EXPAREL ® (bupivacaine liposome injectable suspension) in intercostal nerve block for posterolateral thoracotomy. The study 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 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 this response was less pronounced in patients in Poland and missing in patients recruited in the Czech Republic (there were too few U.S. 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 2 portion of its other pivotal nerve block trial, a femoral nerve block study for total knee arthroplasty; the Phase 3 portion of this study is ongoing. The U.S. Food and Drug Administration (FDA) 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 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.
“While we will further examine the efficacy results for this trial, we are pleased with the initial assessment of safety in this model,” said Dave Stack, president, chief executive officer and chairman of Pacira. “Given the FDA’s position that a single positive pivotal trial would be sufficient for the approval of a nerve block indication and knowing that pain trials frequently fail to meet their primary endpoint, we had already planned two Phase 3 clinical trials as a risk mitigation strategy. We believe that with the positive interim results from the femoral nerve block study and the preliminary safety data from the intercostal block trial, we remain on track for submitting an sNDA next year.”