CHMP recommends approval of Exparel in post surgical pain.- Pacira BioSciences

Pacira BioSciences announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia.The CHMP positive opinion was based on the results of four pivotal Phase III studies that demonstrated improvements in pain reduction and opioid use. These studies include: Lower Extremity Nerve Block Study: This study assessed the safety and efficacy of Exparel as a femoral nerve block in patients undergoing total knee arthroplasty. Results demonstrated that Exparel resulted in a significant reduction in cumulative pain scores over 72 hours compared to placebo. A higher percentage of patients who received Exparel were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control. Upper Extremity Nerve Block Study: This study assessed the safety and efficacy of Exparel as an interscalene brachial plexus nerve block in patients undergoing total shoulder arthroplasty or rotator cuff repair. Results demonstrated that Exparel significantly improved pain control and reduced opioid consumption through 48 hours compared with placebo and a standardized pain management protocol alone. Hard Tissue Infiltration Study: This study assessed the safety and efficacy of Exparel administered via infiltration in patients undergoing bunionectomy. Results demonstrated that Exparel significantly reduced pain and opioid consumption compared with placebo over the first 24 hours following surgery than patients administered placebo. Soft Tissue Infiltration Study: This study assessed the safety and efficacy of Exparel administered via infiltration in patients undergoing hemorrhoidectomy. Results demonstrated that Exparel significantly reduced pain compared to placebo at all time points, including a 30 percent reduction in the cumulative pain scores at 72 hours. Patients who received Exparel consumed significantly fewer opioids than patients administered placebo.