Positive results in Phase III trial of Sufentanil NanoTab PCA (AcelRx Pharmaceuticals) for patients with Post-Operative Pain

Top-line data results demonstrating that the first of two pivotal placebo-controlled Phase III studies for sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System, from AcelRx Pharmaceuticals, met its primary endpoint. The primary endpoint evaluated Pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.

Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (p=0.001). Secondary endpoint data also showed that 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p="0.004" respectively. treatment-emergent adverse events occurred in 64.0 of sufentanil-treated patients and 67.2 of placebo-treated patients.>