AcelRx reports positive results from Phase I pain and anxiety trial

This 24-patient two-cohort, five-arm crossover study included administration of open-label oral triazolam and IV sufentanil on days one and two followed by a double-blinded, randomized dosing of a sublingual NanoTab containing high-dose sufentanil/triazolam, low-dose sufentanil/triazolam and 10mcg sufentanil only on days three to five.

The study demonstrated that administration of ARX-03 resulted in a statistically significant increase in sedation levels for the 10mcg sufentanil/200mcg triazolam dosage strength in both a younger cohort (age range 18-60 years; p=0.009) and an older cohort (age range of 61-80 years; p=0.003) as compared to sublingual sufentanil alone. These data were collected using the Richmond agitation-sedation scale, a validated and objective test for assessment of sedation levels. The average onset of sedation was 20-30 minutes for the higher dosage strength in each study cohort.

Additionally, sublingual administration of the sufentanil/triazolam combination was found to be safe and well tolerated. Based on these positive results, AcelRx intends to further advance clinical development of ARX-03 in 2009.

Pamela Palmer, chief medical officer of AcelRx, said: We believe the results of this trial are particularly valuable as they offer clinical evidence well beyond what is expected from a typical Phase I study. Not only have we shown ARX-03 to be safe and well-tolerated, we have also demonstrated significant pharmacodynamic findings with a randomized, double-blind design that spanned different age groups and multiple dosage levels.