Additional Relevant Details Patient enrollment and dosing in a multicenter, open-label Phase 3 clinical study, known as SAP303, has been initiated. SAP303 is being conducted in patients 40 years and older who have moderate-to-severe acute pain following a surgical procedure. SAP303 will allow patients to be administered one dose of ARX-04 (sufentanil sublingual tablet, 30 mcg) every 60 minutes, as needed for pain management, for up to 12 hours.
SAP303 is expected to enroll up to approximately 100 patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia (except those who received intrathecal opioids). The primary efficacy endpoint is the summed pain intensity difference (SPID) over the 12-hour study period (SPID12). Safety endpoints, such as adverse events and vital signs will also be assessed. The study is expected to be completed by the third quarter of 2016.