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.
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.
For more information call (650) 216–3500 or visit AcelRx.com.