November 2, 2009
AcelRx reported results from a phase II trial of ARX-03, a sublingual formulation of sufentanil plus triazolam, for the reduction of agitation, anxiety and pain during surgical procedures. This randomized, double-blind, placebo-controlled study enrolled 40 subjects who were undergoing an elective low-volume abdominal liposuction procedure. The subjects were randomized to receive either a single sublingual dose of ARX-03 or placebo prior to the injection of a local anesthetic and the subsequent liposuction procedure. The primary endpoint was efficacy of ARX-03 compared to placebo in providing mild sedation during the procedure, as assessed using the validated, objective Richmond Agitation-Sedation Scale (RASS). The cumulative RASS score over the 4-hour study period was significantly better for the ARX-03 arm than for placebo (p<0.001) and a separation from placebo was seen as early as 30 minutes post-dosing (p≡0.046), indicating a rapid onset of sedation. The efficacy of ARX-03 in reducing anxiety compared to placebo, a key secondary endpoint, was reached with significance. The cumulative anxiety score (patient-reported 11-point scale) over 4 hours was significantly lower for ARX-03 than for placebo (p≡0.004), and a separation from placebo was seen as early as 15 minutes post-dosing (p≡0.034), indicating a rapid onset of anxiolysis. In addition, analgesic efficacy (Summed Pain Intensity) which reflects the cumulative pain score over the 4-hour study period was lower for the group treated with ARX-03 relative to those treated with placebo (median values of 13 versus 23 in the active and placebo groups, respectively; p≡0.09).