=Pacira Pharma (PCRX) announces topline phase 3 results for EXPAREL as a single-dose nerve block

Pacira Pharma completes two Phase 3 placebo-controlled studies evaluating the efficacy, safety and pharmacokinetics of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose nerve block for prolonged regional analgesia:

The Upper extremity study showed that EXPAREL significantly reduces pain scores and opioid use.

• Lower extremity study defined safety and pharmacokinetic profile through 120 hours
• Timing for resubmission of supplemental New Drug Application remains on track

Upper Extremity Study: 

• EXPAREL demonstrated statistical significance for the primary endpoint of cumulative pain scores over 48 hours.
• EXPAREL also achieved statistical significance versus placebo for the study's key secondary endpoints
• The preliminary safety analysis was consistent with previously reported studies of brachial plexus nerve blocks with bupivacaine.

Lower Extremity Study:

• EXPAREL did not demonstrate statistical significance in the femoral nerve block study
• The preliminary safety analysis was consistent with previously reported studies of femoral nerve blocks with bupivacaine.

Nerve Block Development Program: 

• EXPAREL demonstrated statistical significance for the primary endpoint of cumulative pain scores over 72 hour
  • The EXPAREL group also had lower mean total opioid use
• The results of the femoral nerve block study were published in the peer-reviewed journal, Anesthesiology (Hadzic et al. Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty Anesthesiology 2016; 124:00-00).

Pacira plans to submit the full results from the Phase 3 studies for presentation at future scientific conferences and for publication in peer-reviewed journals.