Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the publication of results from a pooled analysis of nine clinical trials across five surgical models that compared cumulative pain scores, opioid consumption and occurrence of opioid-related adverse events (ORAEs) following administration of EXPAREL ® (bupivacaine liposome injectable suspension) or bupivacaine HCl. EXPAREL is a non-opioid local analgesic indicated for administration into the surgical site to produce postsurgical analgesia.
Notably, the results of the pooled analysis demonstrated that EXPAREL in a multimodal setting was associated with a statistically significant:
- Reduction in cumulative pain scores through 72 hours ( P=0.039)
- Longer time to first opioid rescue ( P<0.0001)
- Decrease in opioid requirements and incidence of ORAEs
- Significant reduction in opioid use ( P<0.0001)
- Thirty-six percent of bupivacaine HCl patients experienced at least one ORAE compared to 20 percent of EXPAREL patients ( P<0.0001)
“This pooled analysis of over 900 clinical trial patients revealed not only improved pain scores with EXPAREL but also a statistical effect on several aspects of the opioid burden, compared to patients randomized to bupivacaine HCl in a multimodal setting,” said Joseph Dasta, MSc, FCCM, FCCP, RPh, Adjunct Professor at the University of Texas College of Pharmacy, and lead author on the paper. “This EXPAREL-based approach to multimodal pain management, which minimizes exposure to opioids and thus their related adverse events, has the potential to have important economic consequences.”
This analysis pools data from a total of 503 patients who received a single administration of EXPAREL at doses up to 266 mg compared with 409 patients who received bupivacaine HCl at doses up to 200 mg; surgical models included inguinal hernia repair, total knee arthroplasty, hemorrhoidectomy, bunionectomy and breast augmentation. The most frequently reported adverse events in both treatment groups were nausea, constipation and vomiting.