24 hours? gosh, you get that with a 30 cent shot of bupivicaine. this is a joke, right?
In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity; however, there was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated.
there were 2 Phase III trials. First trial: The 300 mg dose of EXPAREL provided a statistically significant 30% reduction in pain (p<0.0001), as measured by the area under the curve, or AUC, of the NRS-R pain scores at 72 hours and all additional time points measured up to 72 hours. Patients in the EXPAREL treatment group showed 45% less opioid usage compared to the placebo treatment group at 72 hours. A greater percentage of patients treated with EXPAREL were “extremely satisfied” compared to the placebo treatment group, and the difference was statistically significant (p=0.0007) at 24 and 72 hours post-dose. Second trial: Total avoidance of opioid rescue medication . The difference between treatment groups in the percentage of patients who received opioid rescue pain medication was statistically significant, favoring the group treated with EXPAREL compared to the placebo treatment group through 12 hours (p=0.0003) and 24 hours (p=0.0404); Delayed use of opioid rescue medication . EXPAREL delayed the median time before first opioid use compared to the placebo treatment group and this difference was statistically significant (p<0.0001); and More pain free patients . A statistically significant increase in the percentage of pain free patients was observed between treatment groups, favoring the group treated with EXPAREL compared to the placebo treatment group at 2 hours (p=0.0019), 4 hours (p=0.0002), 8 hours (p=0.0078) and 48 hours (p=0.0153) post-dose. The difference between groups was not statistically significant at 24 hours post-dose.
FDA asked the company to label conservatively. But you can see the data is there. opioid-related adverse events (ORAEs) are associated with more than a $1,000 increase in hospitalization cost and more than a day increase in length of hospital stay (LOS). So if you spend $150 for EXPAREL, an dsave $1000, then there is a big market ($400-500 mm) for EXPAREL.