AcelRx announced topline results from the Phase 3 SAP302 study of ARX-04 (sufentanil sublingual tablet) for the treatment of moderate-to-severe acute pain associated with trauma or injury in patients presenting to the emergency department.

SAP302 is a single-arm, open-label Phase 3 trial evaluating ARX-04 in two cohorts; an initial phase which included 40 adult patients given a single dose of ARX-04, and an extension phase enrolling 36 patients eligible for up to 4 doses of as needed ARX-04. 

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Study results showed that patients treated with ARX‑04 (n=76) experienced a mean pain intensity difference to baseline (PID) of 2.9 from a baseline of 8.1 (35%) on a 0–10 numeric rating scale at 60 minutes, with a decrease from baseline of 2.7 in the first cohort vs. 3.1 in the second cohort. Additionally, results from the second cohort showed that 75% of patients experienced sufficient pain relief with only a single dose of ARX‑04. Of the 36 patients in the cohort, 7 received a second dose of ARX‑04, 2 received a third dose, and 8% receive morphine as additional pain relief.

The study also found that ARX-04 demonstrated a predicted onset of activity, with a mean pain intensity decrease of 1.1 compared to baseline 15 minutes after first administration, and a decrease of 1.9 after 30 minutes. ARX-04 demonstrated a tolerable safety profile, with the most common adverse events including nausea, somnolence, and vomiting.

ARX-04 is an investigational product consisting of sufentanil sublingual tablets, 30mcg, delivered via a disposable, pre-filled, single-dose applicator (SDA). It is funded in part by the Clinical and Rehabilitative Medicine Research Program of the U.S. Army Medical Research and Materiel Command.

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