ARX 04 (sufentanil sublingual tablet) meets endpoints in phase III trial for acute pain- AcelRx Pharma

AcelRx Pharmaceuticals announced that ARX 04 (sufentanil sublingual tablet, 30 µg) met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase III trial (SAP301) designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery. Results demonstrated that patients receiving ARX 04, administered via a disposable, pre-filled, single-dose applicator (SDA), experienced significantly greater pain reduction compared to placebo, as measured by the time-weighted summed pain intensity difference over the first 12 hours of treatment (SPID-12) (p<0.001).

Adverse events reported in the study were typical of opioid therapy and were similar for patients treated with ARX 04 and placebo, the most common of which were nausea, headache and vomiting. There were two serious adverse events (SAEs) reported during the study period, both of which were in the placebo group and resulted in early termination of the study in the affected patients.

Comment: AcelRx is hoping to target ARX 04 to patients such as wounded soldiers on the battlefield, trauma victims at the site of a road-traffic accident, migraine patients in the emergency room, or for general patients in moderate-to-severe acute pain where intravenous access is not readily available.