Additional Relevant Details The extension phase of the SAP302 study of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury has been initiated. This ongoing open-label Phase 3 study has completed the initial phase, enrolling 40 patients who each received a single dose of ARX-04. In this extension phase, up to an additional 100 patients may be enrolled, each of whom may receive multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. The primary endpoint of SAP302 is the time-weighted summed pain intensity difference to baseline over one hour, or SPID-1.