Pacira Pharmaceuticals Announces Results from EXPAREL Pivotal Trial Published in Diseases of the Colon & Rectum

Pacira Pharmaceuticals PCRX today announced the publication of data from a placebo-controlled, pivotal Phase 3 trial of EXPAREL™ (bupivacaine liposome injectable suspension), a non-opioid local analgesic that was recently approved by the U.S. Food and Drug Administration for administration into the surgical site to produce postsurgical analgesia. The results, which demonstrate statistically significantly lower pain scores and decreased opioid requirements for up to 72 hours with EXPAREL, were published in the December print edition of the peer-reviewed journal Diseases of the Colon & Rectum. The multicenter, randomized, double-blind, placebo-controlled study compared the magnitude and duration of postsurgical analgesia from a single dose of EXPAREL with that of placebo administered intraoperatively via deep tissue infiltration in patients undergoing a two- or three-column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique. Patients in both populations who experienced inadequate pain control were eligible to receive opioids for rescue pain relief. The primary efficacy endpoint was postsurgical pain control, measured by assessing patients' cumulative pain score, a measure of pain intensity over time, through 72 hours. Opioid use and patient satisfaction were also investigated.