According to the company, Exparel provided safe and well-tolerated analgesia with normal wound healing in all patients. The study also showed significant reductions in pain with activity in Exparel treated patients compared to active control and a positive trend toward lower opioid use in all Exparel groups compared to active control.
In addition, the study demonstrated dose-proportional sustained plasma concentrations which support the prolonged local release of bupivacaine. More patients who received Exparel avoided opioids altogether, compared to active control, the company said.
Exparel, a proprietary product of Pacira, is a novel long-acting, sustained-release formulation of bupivacaine HCL, a local anesthetic used for treating postoperative pain. The dose-escalating study evaluated the efficacy, safety and pharmacokinetics of Exparel compared to bupivacaine HCL in 76 adult male patients (age ranges 48 to 63) in 10 hospitals in the UK and Australia.
Subjects were randomized into one of four cohorts and intraoperatively administered either 175mg, 225mg, 300mg or 325mg of Exparel or 100mg bupivacaine HCL around the surgical wound by infiltration immediately before closure.
Ronald Burch, chief medical officer of Pacira, said: Exparel, currently in late Phase III clinical development, is being studied in several different types of surgical procedures where postoperative pain management is especially problematic and where the need for prolonged analgesia via a single administration can provide a significant improvement in pain relief, especially during the first 72 hours following surgery when pain is most intense.