Objective The objective of this study was to validate the ease of assembly and application of the sumatriptan iontophoretic transdermal system (sumatriptan TDS, Zecuity((R)), NuPathe, Inc., Malvern, PA, USA) during a migraine attack. Background Iontophoresis is a noninvasive drug delivery method using low electrical current to move solubilized drugs across the skin to the underlying tissue. With sumatriptan TDS, a pre-programmed dose of sumatriptan is automatically delivered via a transdermal patch, allowing therapeutic drug levels to be reached without mechanical penetration or disruption of the skin. Because migraine attacks can be disabling, with many patients unable to perform their usual activities, it is important for prescribers and their patients to be confident that they will be able to assemble and apply sumatriptan TDS in the middle of an attack. A human factor use study was conducted to evaluate the ease of assembly and application of the sumatriptan TDS among migraineurs and healthcare professionals (HCPs) who are likely to instruct patients on how to use the patch. Methods This was a single-center, open-label study assessing a single use of sumatriptan TDS in adult migraineurs and HCPs. Subjects were divided into 3 groups: migraineurs trained to use sumatriptan TDS, migraineurs not trained to use sumatriptan TDS, and HCPs not trained to use sumatriptan TDS. Sixteen subjects (trained migraineurs and untrained HCPs) participated in a preliminary usability test, and 48 subjects (16 representing each of the 3 groups) participated in a formal final test. Subjects were 20-64 years old, inclusive, and 83% female. They rated usability on a scale of 1-7, with 1 being difficult and 7 being easy. Results Preliminary testing.-Of the 16 sumatriptan TDS patches assembled and applied, 100% (16/16) were assembled and applied successfully. The mean score for ease of assembly was 6.3, and the mean score for ease of application was 6.8 out of 7, with 1 being difficult and 7 being easy. No modifications were made to patient instructions for use, patient labeling, or patient video for the final phase of testing. Final testing.-Of the 48 sumatriptan TDS patches assembled and applied during final testing, 100% (48/48) were assembled and applied successfully, with no user errors, one close call, and no operational difficulties observed. Across all 3 groups, the mean score for ease of assembly was 6.1, and the mean score for ease of application was 6.8 out of 7, with 1 being difficult and 7 being easy. For migraineurs who were trained and subsequently returned to the testing facility for evaluation of usability while in distress of a mild to severe migraine attack, the number of days between training and testing ranged from 0 to 20, with a mean of 3.6. Among untrained and trained migraineurs, 3.1% had a mild attack, 68.8% had a moderate attack, and 28.1% had a severe attack. Conclusions The results of this study indicate that sumatriptan TDS can be assembled and applied successfully during a mild to severe migraine attack. Across all subject groups in both the preliminary and final testing, including trained and untrained migraineurs in distress of a migraine attack (96.9% moderate to severe) and untrained HCPs not experiencing a migraine attack, patch assembly and application was 100% successful. In the final test, subjects rated sumatriptan TDS very high for ease of assembly (6.1 out of 7, with 7 being easy) and ease of use (6.8 out of 7, with 7 being easy). These results indicate that patients and HCPs can be confident that patients can readily assemble and use sumatriptan TDS during a migraine attack. Short Summary A human factor use study evaluating ease of assembly and application of the sumatriptan transdermal system (TDS) among 64 migraineurs and HCPs found that patch assembly and application was 100% successful. Sumatriptan TDS scored 6.1 out of 7 for ease of assembly and 6.8 out of 7 for ease of use (with 7 being easy). Patients and HCPs can be confident that patients can assemble and use sumatriptan TDS during a migraine attack.
