Objective: Characterize acute episodes of nausea experienced by patients with Parkinson’s disease (PD) receiving apomorphine sublingual film (APL) for the on-demand treatment of “OFF” episodes.

Background: In a 12-wk pivotal study (NCT02469090), APL was efficacious and generally well tolerated for on-demand treatment of “OFF” episodes in patients with PD. APL is approved by the United States Food and Drug Administration for the acute, intermittent treatment of “OFF” episodes in patients with PD.

Method: 141 patients with PD and “OFF” episodes on stable PD medications were enrolled. During dose titration (DT), patients in a practically-defined “OFF” state received APL (10–35 mg) in 5 mg increments at separate clinic visits until a FULL “ON” and tolerable response was achieved within 45 min. Antiemetics (trimethobenzamide 300 mg TID or domperidone 10 mg BID) were required during DT, beginning 3 days prior to the first DT visit. Acute episodes of nausea, defined as those that began following administration of single doses of APL during DT, are reported descriptively.

Results: Nausea occurred in 29/141 (21%) patients during DT: 22 (16%) experienced acute episodes of nausea during clinic visits; 7 (5%) reported intermittent nausea outside of clinic visits and not immediately following APL administration. Acute episodes of nausea varied by dose, occurring in 10/141 (7%) patients with 10 mg APL, 6/123 (5%) with 15 mg, 5/88 (6%) with 20 mg, 3/57 (5%) with 25 mg, 4/36 (11%) with 30 mg, and 2/20 (10%) with 35 mg. Mean time to onset of acute episodes of nausea after APL administration (from the time the strip was placed under the tongue) was 27.7 [7–57] min and mean duration of acute nausea episodes was 46.2 [2–100] min. Most acute episodes of nausea were mild (57%), with 30% classified as moderate and 13% as severe. Vomiting occurred in 2 patients who experienced severe nausea and 1 patient who experienced moderate nausea. In 87% of instances of acute nausea, the dose of APL was unchanged during DT; 3 patients who experienced acute episodes of nausea withdrew from the study during DT.

Conclusion: In this post hoc analysis, patients who reported acute episodes of nausea following APL administration during DT experienced mostly mild events lasting less than 1 hour in duration. Acute episodes of nausea rarely impacted patients’ ability to continue treatment with APL.

« Back to MDS Virtual Congress 2021

MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-parkinsons-disease-characterization-of-acute-nausea-during-dose-titration/