Intermittent Subcutaneous Apomorphine Therapy for ‘Off’ Episodes in Parkinson’s Disease: A 6-Month Open-Label Study

Purpose: The outpatient follow-up phase of the apomorphine (APO) 303 study assessed the long-term efficacy and safety of intermittent subcutaneous apomorphine for ‘off’ episodes in patients with advanced Parkinson’s disease. Methods: We conducted a 6-month open-label outpatient extension of an inoffice dose-escalation study. Patients received apomorphine at a dose considered optimal based on safety and efficacy assessments during the dose-titration phase. Outpatient evaluation visits were scheduled at 1 and 2 weeks, and 1, 4 and 6 months. Efficacy parameters included changes in Unified Parkinson’s Disease Rating Scale (UPDRS) motor scores; safety assessments included blood pressure (BP) monitoring. Results: Apomorphine significantly (p < 0.05) reduced UPDRS motor scores at 20, 40 and 90 minutes post-dose versus pre-dose at all evaluation visits. Significant (p < 0.1) reductions from pre-dose in seated and standing systolic BP and diastolic BP were noted at various timepoints post-dose at evaluation visits; however, the changes did not increase over the course of the outpatient phase. The incidence of symptomatic hypotension also did not increase with long-term apomorphine use. Conclusions: The efficacy and general tolerability of subcutaneous apomorphine throughout this open-label outpatient study suggest that it is suitable for the long-term acute treatment of ‘off’ episodes in patients with advanced Parkinson’s disease.