AcelRx Pharmaceuticals Presents ARX-04 Dose-Finding Phase 2 Study Data

AcelRx Pharmaceuticals

today presented additional detail from the Phase 2 dose-finding study of ARX-04, an investigational single-dose sublingual sufentanil NanoTab for moderate-to-severe acute pain, for which topline results were reported in April 2013. Patients treated with the 30 mcg dose of sufentanil showed a rapid onset of action with a statistically significant beneficial difference in pain relief (p<0.001) and pain intensity (p<0.01) seen at 30 minutes after dosing compared to placebo.  Dosing averaged every 2.4 hours over the duration of the 12-hour study.  In addition, patient global assessment of the 30 mcg dose at 12 hours was superior to placebo (p=0.002) with 43.6% vs. 5.0% of the patients responding good or excellent for overall pain control. The 20 mcg dose was not significant for either endpoint.  This study was funded by a grant from the U.S. Army Medical Research and Materiel Command. These results are