Objective: To compare the safety profile of clinic versus home dose optimization of apomorphine sublingual film (SL-APO) in patients with Parkinson’s disease experiencing OFF episodes.

Background: In previous SL-APO clinical studies, both initiation and dose optimization were performed entirely in a clinical setting to assess tolerability, including potential orthostatic hypotension-related syncope.

Method: In the SL-APO pivotal study, both open-label dose initiation and optimization (10‒35 mg; 5-mg increments) occurred entirely in clinic [1]. In a separate crossover study comparing SL-APO and subcutaneous apomorphine, both drugs were initiated and optimized sequentially in a random fashion (randomized to SL-APO first, n=57) [2]. SL-APO was initiated at 10 mg in a clinical setting, while dose optimization (15‒30 mg; 5-mg increments) could continue at home without direct supervision (performed by 81% of patients) until the patient felt an optimal response was achieved; optimal dose was confirmed by the investigator in clinic. Treatment-emergent adverse events (TEAEs) reported during dose optimization of each study are presented.

Results: Comparable percentages of patients in the pivotal (N=141) and crossover (N=102) studies reported ≥1 TEAE (58% vs 63%, respectively) during SL-APO dose optimization. A higher percentage of pivotal study patients versus crossover study patients reported severe TEAEs (9% vs 2%) and TEAEs leading to drug withdrawal (9% vs 4%). Fewer patients experienced orthostatic hypotension in the pivotal study versus the crossover study (1% vs 4%). Presyncope and syncope were experienced by 1% of patients each in the pivotal study and by no crossover study patients. Nausea was the most frequently reported TEAE in the pivotal (21%) and crossover studies (31%) and the most frequent TEAE leading to drug withdrawal, with a similar incidence in both studies (2.1% vs 2%, respectively). Comparable percentages of patients in both the pivotal and crossover studies reported dizziness, somnolence, and fatigue. Fewer pivotal study versus crossover study patients reported dyskinesia.

Conclusion: After initiation in clinic, data from the pivotal and crossover studies suggest that the safety profile of SL-APO home dose optimization is comparable to clinic dose optimization.

References: 1. Olanow et al., Lancet Neurol. 2020; 19(2):135-144.
2. Rascol et al. Mov Disord. 2022; 37(suppl 1); abst 760 – poster

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MDS Abstracts - https://www.mdsabstracts.org/abstract/clinic-versus-home-dose-optimization-of-apomorphine-sublingual-film-in-parkinsons-disease-cross-study-comparison-of-safety/