Phase III study of Sufentanil NanoTabs (AcelRX Pharmaceuticals) shows non-inferiority to morphine for Acute Pain

Top-line results of the Phase III clinical trial demonstrate that in treating Acute Pain, the Sufentanil NanoTab PCA System, from AcelRX Pharmaceuticals, was non-inferior to intravenous (IV) patient-controlled analgesia (PCA) with morphine as determined by the combined percentage of patients with Patient Global Assessment (PGA) ratings of "good" or "excellent" (78.5% vs. 66.1% respectively). This statistically superior PGA was also seen at the 24 hour and 72 hour time points.

Additionally, the percentage of patients rating the NanoTab System as "Excellent" was higher than those rating IV PCA morphine as excellent (42.9% vs. 30.6%). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due to an adverse event (7.9% vs. 11.1% respectively). Results were presented at the New York State Society of Anesthesiologists PostGraduate Assembly meeting.