Pacira Pharmaceuticals has announced that its second Phase III trial of EXPAREL (bupivacaine liposome injectable suspension) in intercostal nerve block for posterolateral thoracotomy failed to meet its primary endpoint.
With broad applications across a range of surgical specialities, EXPAREL is currently indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
Designed to assess the safety and efficacy of EXPAREL, the study’s primary endpoint is reduction of cumulative pain scores over 72 hours.
Pacira president, CEO and chairman Dave Stack said the efficacy results for the trial will be assessed further.
"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," Stack added.
"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."
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The double-blind study randomised 180 patients across the US, Bulgaria, Georgia, Poland and the Czech Republic with either 266mg of EXPAREL or placebo.
Patients recruited in Bulgaria and Georgia demonstrated a favouring response to EXPAREL compared with placebo, while the response was less pronounced in patients in Poland and absent in patients recruited in the Czech Republic.
US patients in the study were too few to be meaningful, according to the company.
The company is currently analysing the results to better understand the occurrence of different results among patients belonging to different countries.