AcelRx: ARX-04 Phase 3 Trial Meets Endpoints For Moderate-to-Severe Acute Pain

(RTTNews) - AcelRx Pharmaceuticals, Inc. (ACRX) announced that ARX-04 met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery. The company said the results from the study demonstrated that patients receiving ARX-04, administered via a disposable, pre-filled, single-dose applicator, 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. The company said the adverse events reported in the study were typical of opioid therapy and were similar for patients treated with ARX-04 and placebo.

ARX-04 is an investigational product candidate consisting of sufentanil sublingual tablets, 30 mcg, delivered via a disposable, pre-filled, single-dose applicator. AcelRx is developing ARX-04 for the management of moderate-to-severe acute pain in a variety of medically supervised settings.