Results from second Phase III placebo controlled study of EXPAREL announced

Dec 2 2009

Pacira Pharmaceuticals, Inc., announced today that its second Phase III placebo controlled study of EXPAREL(TM) (DepoBupivacaine) met its primary endpoint. The multicenter, randomized, double-blind, parallel group, placebo controlled study in hemorrhoidectomy showed a statistically significant reduction in area under the curve analysis (AUC) of the NRS pain scores in patients receiving EXPAREL(TM) compared to placebo through 72 hours (p<0.0001).

The study also demonstrated opioid sparing through multiple secondary endpoints:

• The percentage of patients who were opioid free was statistically significantly higher (p<0.0008) in the EXPAREL(TM) group compared to the placebo group.
• Median time to 1st opioid rescue was 1 hour and 10 minutes in the placebo group, and 14 hours and 20 minutes in the EXPAREL(TM) group. This difference was statistically significant (p<0.0001).
• EXPAREL(TM) patients showed a statistically significantly reduced total opioid consumption through 72 hours compared to the placebo group>

EXPAREL(TM) was well tolerated, with the incidence of adverse events similar to placebo. GI side effects, commonly associated with opioid use, were reduced in the EXPAREL(TM) group compared to placebo. No serious adverse events were reported in patients receiving EXPAREL(TM).

The Phase III trial studied 189 patients to determine the safety and efficacy of a single administration of EXPAREL(TM) for prolonged post operative analgesia in patients undergoing hemorrhoidectomy.

In October 2009 the Company reported positive data from a placebo controlled Phase III study in patients undergoing bunionectomy.

"We are delighted to announce the positive results from our second Phase III placebo controlled clinical trial," commented Gary Patou, MD, Chief Medical Officer for Pacira. "In this latest study we were able to demonstrate the analgesic effect of EXPAREL(TM) at every interval up to 72 hours post operative in a soft tissue setting. The earlier positive Phase III study demonstrated an analgesic effect in an orthopedic setting. Both studies met their primary endpoints."