Clinical Data Overall, the 76 adults treated with ARX-04 in this study experienced a mean pain intensity difference to baseline (PID) of 2.9 from a baseline of 8.1, or 35%, on a 0 – 10 numeric rating scale at 60 minutes.SAP302 enrolled patients in two cohorts. The initial phase enrolled 40 adults who were administered a single dose of ARX-04; and an extension phase enrolled 36 adults who were eligible to receive up to four doses of ARX-04, given hourly as needed for pain. Interim results from the first cohort were reported in February 2016, and showed that patients treated with a single dose of ARX-04 experienced a mean pain intensity decrease from baseline of 2.7 at 60 minutes. Patients in the second cohort reported a mean pain intensity decrease from baseline of 3.1 on the 0 – 10 pain intensity scale at 60 minutes. Of these 36 patients, seven received a second dose of ARX-04, and two received a third dose. For 75% of patients in the second cohort, a single dose of ARX‑04 was sufficient for pain relief and only 8% of patients received morphine in addition to ARX-04.In addition, ARX-04 demonstrated a predicted onset of activity in patients enrolled in SAP302. Patients reported a mean pain intensity decrease of 1.1 compared to baseline 15 minutes following first administration of ARX-04, and a decrease of 1.9 after 30 minutes.Overall ARX-04 was well tolerated in this study, with 79% of patients reporting no adverse events. The most common adverse events reported in the study occurred with single-digit rates - the most common being nausea (9%), somnolence (5%) and vomiting (4%). All these events were rated as mild with the exception of one event of moderate nausea. Drug-induced cognitive impairment was not seen with ARX-04 in this study, as assessed using the validated Six-Item Screener.