Pacira Pharmaceuticals reported positive results from its Phase III trial assessing safety and efficacy of EXPAREL (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty. The company said the trial met its primary efficacy endpoints.
Dave Stack, President, Chief Executive Officer and Chairman of Pacira, said, “We are pleased to report the positive results of the femoral nerve block trial and look forward to filing for a nerve block indication. We believe that the expansion of the EXPAREL label to include nerve block will further enhance its clinical utility and broaden its access among anesthesiologists and surgeons.”
EXPAREL is indicated for single-dose infiltration to produce postsurgical analgesia in the surgical site. EXPAREL combines bupivacaine with a product delivery device called DepoFoam. The drug represents the first and only multivesicular liposome local anesthetic which can be used in the peri- or postsurgical setting in the same manner as existing local anesthetics. Using EXPAREL with DepoFoam provides analgesia with reduced opioid requirements for up to 72 hours. When used as part of a multimodal therapy regimen, the drug can provide non-opioid pain control that lasts as long as the duration of most intense postsurgical pain without necessitating use of catheters, pumps, and other delivery devices.
The randomized Phase III trial assessed 183 patients who received either 266 mg of the drug or placebo. All patients were offered rescue narcotics as needed. Trial results showed 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 deemed comparable between the two randomized patient groups.
Previous pivotal studies have shown EXPAREL’s safety and efficacy in patients undergoing bunionectomy or hemorrhoidectomy procedures. The drug has been evaluated in 21 clinical trials involving over 1,300 patients. More studies are underway to further establish EXPAREL’s safety and efficacy in other procedures.