Pacira reports Phase III study results for EXPAREL for prolonged post operative analgesia.
M2 EUROPHARMA-(C)1999-2009 M2 COMMUNICATIONS
2 December 2009 - US acute care specialty pharmaceutical company Pacira Pharmaceuticals Inc said yesterday that its second Phase III study of EXPAREL (DepoBupivacaine) for prolonged post operative analgesia in patients undergoing hemorrhoidectomy met its primary endpoint.
EXPAREL is a novel long-acting, sustained release formulation of bupivacaine HCl, a local anesthetic/analgesic widely used for treating post operative pain.
The multi-centre, randomised, 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 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 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 group. This difference was statistically significant (p<0.0001); EXPAREL patients showed a statistically significantly reduced total opioid consumption through 72 hours compared to the placebo group(p=0.0006).
EXPAREL 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 group compared to placebo. No serious adverse events were reported in patients receiving EXPAREL. The Phase III trial studied 189 patients to determine the safety and efficacy of a single administration of EXPAREL for prolonged post operative analgesia in patients undergoing hemorrhoidectomy.
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|Article Type:||Clinical report|
|Date:||Dec 2, 2009|
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