Sublingual Sufentanil Demonstrates Efficacy in Phase 3 Trial
AcelRx Pharmaceuticals announced that ARX-04 (sufentanil sublingual tablet) met primary and secondary endpoints in its Phase 3 SAP301 trial for the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery.
SAP301 is a Phase 3, multi-center, double-blind, placebo-controlled trial which enrolled adult patients undergoing outpatient abdominal surgery procedures. Following surgery, 163 patients were randomized to receive either ARX-04 or placebo in a 2:1 active to placebo ratio. The intent-to-treat (ITT) population averaged 40.9 years of age with an average Body Mass Index (BMI) of 27.5, and a female to male percentage of 68%:32%, respectively. The primary endpoint of the study was the difference in the summed pain intensity difference over the first 12 hours of treatment (SPID-12) score of patients receiving ARX-04 compared to placebo.
Results demonstrated that patients receiving ARX‑04 experienced significantly greater pain reduction compared to placebo, as measured by the time-weighted SPID-12 score (P<0.001). SPID‑12 scores were +25.8 for ARX-04-treated patients and +13.1 for placebo-treated patients. The difference in pain intensity from baseline was also superior for ARX-04 over placebo at the earliest time point measured (15 minutes; P=0.002).
ARX-04 is an investigational product consisting of sufentanil sublingual tablets, 30mcg, delivered via a disposable, pre-filled, single-dose applicator (SDA).
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