Usability of the Sufentanil NanoTab PCA System: results from three human factors studies

The Sufentanil NanoTab® PCA System (ARX-01) is a novel, non-invasive, preprogrammed approach to patient-controlled sublingual analgesia currently in development that avoids the issues of medication and programming errors which occur with intravenous patient-controlled analgesia (PCA). Patients can utilize the System to deliver 15 mcg sufentanil tablets with a 20-minute lockout between doses. Radiofrequency identification uniquely matches each patient to the device. Two randomized, placebo-controlled Phase 2 studies and an open-label device functionality study demonstrated that sublingual sufentanil is efficacious and well tolerated in treating post-operative pain after major orthopedic or abdominal surgery. Three randomized, controlled Phase 3 trials are nearing completion. Human factors (HF) studies are an important aspect of drug/device development to allow end-user feedback on system design features, functionality, and usability. Three ARX-01 HF studies are reported here. Study 1 involved 19 nurse and central sterile/biomedical engineer participants without prior System training to assess the Instructions for Use (IFU) guide for comprehension. Study 2 involved 15 nurse participants with sessions conducted over a 4-day period. All nurses in Study 2 set up and programmed PCA pumps at least three times per week. Study 3 included 15 nurses and 15 ”patient participants” (healthy male and female volunteers up to 80 years of age who spoke and read English fluently). Sessions were conducted over a 7-day period. No nurse PCA experience was required in Study 3. Study 3 “patient” participants averaged 61.5 years of age, were at least high school graduates. The ARX-01 System was found to be easy to use and the IFU well organized and relatively understandable. After a short period of training, nurses were able to successfully complete tasks most of the time with little prompting or referral to the user manual. Similarly, the “patient” participants found the System easy to use. Sponsored by AcelRx Pharmaceuticals.