Parsippany-Troy Hills, N.J.-based Pacira Pharmaceuticals announced its Phase 4 study of Exparel in patients undergoing total knee arthroplasty has reached statistical significance.
Here are five things to know:
1. The Exparel study has reached levels of statistical significance for post surgical pain, opioid reduction, time to first opioid use and the percentage of patients who didn't require opioids to treat their post-TKA surgical pain.
2. Co-primary efficacy endpoints were the area under the curve of the pain intensity scores measured on a visual analog scale from a range of 12 to 48 hours after surgery. Total opioid consumption was expressed as morphine equivalents from 0 to 48 hours post-surgery.
3. Patients who received Exparel experienced a significant pain score reduction compared to those who didn't. Patients who received Exparel also consumed fewer opioids than those who hadn't received Exparel in the 48 hours following the surgery.
4. A recent study reveals one in 10 opioid naïve patients become dependent on it six months after opioid-driven post surgical pain management.
5. Pacira chairman and CEO Dave Stack said, "The results of this study provide further evidence that Exparel effectively reduces, and in some cases, eliminates the use of opioids while providing prolonged postsurgical pain relief to patients undergoing complex and painful knee replacement surgery with a simple inexpensive multimodal design."
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