Motor Responses to Apomorphine Sublingual Film Compared With Levodopa in Patients With Parkinson’s Disease and “OFF” Episodes
Jennifer Hui1, Susan Fox2, William Neeson3, Kenneth Sciarappa4, Eric Pappert4, Bradford Navia4
1Keck School of Medicine of USC, University of Southern California, 2Toronto Western Hospital, 3Sunovion Pharmaceuticals Canada Inc., 4Sunovion Pharmaceuticals Inc.
Objective:

To compare motor improvement after apomorphine sublingual film (APL) versus levodopa administration in patients with Parkinson’s disease (PD) and “OFF” episodes.

Background:
APL is approved for the on-demand treatment of “OFF” episodes associated with PD in the United States and Canada. Analysis of pivotal study (NCT02469090) data indicated earlier onset of motor improvement and peak response with APL vs levodopa in patients with PD and “OFF” episodes. Analysis with expanded data from a long-term safety study (NCT02542696) was performed.
Design/Methods:
Patients with PD and “OFF” episodes taking stable PD medications were enrolled in the pivotal or long-term studies. APL titration occurred during sequential office visits when patients were “OFF” to determine the dose (10–35 mg; 5-mg increments) resulting in a tolerable FULL “ON” within 45 minutes. Motor responses after open-label APL and usual-dose levodopa administration were compared using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score, assessed predose and 15, 30, and 60 minutes postdose. The percentage of responders (≥30% reduction in Part III score vs predose) was also assessed.
Results:
Overall, 384 patients received APL and levodopa. Predose mean MDS-UPDRS Part III scores were comparable (APL, 41.9; levodopa, 42.2). Mean motor response with APL vs levodopa, respectively, was approximately 2-fold higher at 15 minutes postdose (–13.9 vs –6.7) and remained higher at 30 minutes (–22.9 vs –16.3); the levodopa peak response occurred at 60 minutes (–24.3 vs –24.4). More patients were responders to APL vs levodopa, respectively, at 15 (52% vs 21%) and 30 minutes (88% vs 65%); responder rates were similar at 60 minutes (88% vs 92%).
Conclusions:
Consistent with previous findings, apomorphine sublingual film was associated with greater motor improvement and more responders at earlier time points versus levodopa, further supporting its use in patients with a delayed “ON” response to levodopa.