In this pooled retrospective data analysis, the subset of patients who experienced more than 2.5 hours of OFF time and at least an hour of troublesome dyskinesia a day (101 patients out of total 198 enrolled in clinical trials) were evaluated which showed an improvement of 3.4 hours per day in good ON time on GOCOVRI, compared to placebo. This improvement in good ON time was due to a reduction in the number of hours spent in OFF as well as the hours spent ON with troublesome dyskinesia. In addition to increasing good ON time, patient-reported assessments showed GOCOVRI demonstrated significant improvements in the impact of their symptoms on daily activities and provided more continuous ON time without interruptions from OFF and dyskinesia episodes.
The reduction of OFF was measured as a secondary outcome in the Phase 3 trials for GOCOVRI. Recent OFF trials typically require participants to experience 2-3 hours a day of OFF time at baseline, therefore the subset of patients in this post-hoc study evaluated those who had at least 2.5 hours of OFF time a day.