Pacira Pharmaceuticals announced that the Phase 3 trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint.
The Phase 3 trial evaluated 183 patients who were randomized to receive either 266mg of Exparel or placebo. All patients in the study were offered rescue narcotics as needed. Results demonstrated statistical significance in favor of Exparel for cumulative pain scores over 72 hours as measured by the area under the curve (AUC) (P<0.0001). The preliminary safety analysis was comparable between the two groups.
Exparel combines bupivacaine with DepoFoam, a product delivery technology that delivers medication over a desired time period, providing analgesia with reduced opioid requirements for up to 72 hours. It is the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics.
The FDA has already approved Exparel for administration into the surgical site to produce postsurgical analgesia. Studies have demonstrated the safety and efficacy of Exparel in patients undergoing bunionectomy or hemorrhoidectomy procedures. Additional studies are underway to further demonstrate the safety and efficacy in other procedures.
For more information call (973) 254-3560 or visit Pacira.com.