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Morning ON With APOKYN1

Morning akinesia is often cited as one of the first levodopa complications that a patient recognizes upon awakening.2

Morning akinesia is when patients wait a prolonged period of time before they experience a therapeutic response from their first morning levodopa dose.3 It is a common clinical manifestation of delayed ON.2,3

In a Phase IV Morning Akinesia Study With APOKYN, Patients:

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had significantly fewer dose failures compared with usual morning levodopa dosing3

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had around an 18-point improvement on UPDRS III motor scores3

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showed improvement in their time to ON (primary endpoint)3

Study Adverse Events: Adverse events (AEs) occurring at a level of ≥5% in in the safety population (n=127) were nausea (26.8%), dizziness (16.5%), yawning (10.2%), somnolence (7.9%), hypotension (7.9%), and vomiting (7.1%). The most common AEs leading to discontinuation were hypotension (6.3%), nausea (5.5%), vomiting (5.5%), and dizziness (5.5%).3

Study design: Phase IV, multicenter, open-label study to assess the effect of APOKYN on time to ON in PD patients with morning akinesia (n=127, safety population; n=88, full analysis set). Subjects completed a 7-day oral levodopa baseline period and a 7-day APOKYN treatment period, after dose titration/optimization and antiemetic therapy. The primary efficacy endpoint was time to ON in the APOKYN treatment period versus the baseline oral levodopa period. Secondary assessments included global impression scales.3

Study limitations: Open-label design and pragmatic definition of “dose failure” where all patients who did not turn ON within 60 minutes had their time-to-ON imputed to 100 minutes, an arbitrary threshold. It’s possible this strategy may have led to overestimation or underestimation of mean time-to-ON with levodopa. The study design evaluating time to onset in patients with morning akinesia does not fully reflect clinical practice when APOKYN can be intermittently added to oral PD medications throughout the day.3