. announced Aug. 2 results fromits second pivotal, Phase III clinical trial assessing the safety andefficacy of Exparel (bupivacaine liposome injectablesuspension) in intercostal nerve block for posterolateral thoracotomy, noting that the study did not achieve its primary endpoint of a reduction ofcumulative 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 mgof Exparel or placebo. Patients recruited in Bulgaria and Georgiademonstrated a response favoring Exparel over placebo, but this responsewas less pronounced in patients in Poland and missing in patientsrecruited in the Czech Republic. The company notes that there were too few U.S. patients in thestudy to be meaningful.
In May 2013, Pacira reportedpositive findings from the Phase III portion of its other pivotalnerve block trial, a femoral nerve block study for total kneearthroplasty. The Phase III portion of this study is ongoing, but the
U.S.Food and Drug Administration (FDA) indicated to the company at its end-of-Phase II meeting that a single pivotal trial meeting its primaryendpoint would be sufficient to gain approval for the nerve blockindication, assuming demonstration of adequate safety.
As such, Pacira plans tosubmit data from the ongoing femoral nerve block study to demonstrateefficacy and safety, as well as safety data from the intercostal nerveblock study, for a supplemental New Drug Application (sNDA) anticipatedin early 2014.
"While we will further examine the efficacy results for this trial, weare pleased with the initial assessment of safety in this model," saidDave Stack, president, CEO and chairman of Pacira."Given the FDA's position that a single positive pivotal trial would besufficient for the approval of a nerve block indication and knowing thatpain trials frequently fail to meet their primary endpoint, we hadalready planned two Phase III clinical trials as a risk mitigationstrategy. We believe that with the positive interim results from thefemoral nerve block study and the preliminary safety data from theintercostal block trial, we remain on track for submitting an sNDA nextyear."
Exparel is currently indicated for single-dose administration into thesurgical site to produce postsurgical analgesia.
SOURCE: Pacira news release
