Objective: To assess the occurrence of orthostatic hypotension (OH) during apomorphine sublingual film (SL-APO) dose-optimization in patients with Parkinson’s disease (PwPD).

Background: SL-APO has been shown to be an effective and generally well-tolerated on-demand treatment for OFF episodes in PwPD [1,2]. Several dopamine agonists have been associated with orthostatic hypotension.

Method: In two pivotal trials (CTH-300 and CTH-302) SL-APO was optimized in PwPD and OFF episodes to obtain an effective and tolerable dose. Patients’ blood pressure was measured before and 1h after SL-APO intake when they visited clinics during the dose-optimization phase. We post-hoc analyzed OH-related treatment-emergent adverse events (TEAEs), BP readings, and their co-occurrence.

Results: At 652 dose-optimization visits from 240 patients, mean BP readings before and after SL-APO intake were comparable. In these visits, the frequency of OH appearing after SL-APO intake was similar to the frequency of OH occurring at pre-dosing only. Correspondingly, visits with reported OH-related TEAEs (5.4% of total visits) were accompanied by OH, based on BP readings, at a comparable frequency before and after SL-APO intake only (see Table).

Conclusion: Overall, SL-APO did not affect general BP readings nor the frequency of OH as assessed by those readings during dose-optimization at in-clinic visits (co-occurring with or without reported OH-related TEAEs).

References: 1. Olanow et al., Lancet Neurol. 2020;19(2):135-144
2. Stocchi et al., Mov Disord 2022;37(Suppl 1, abstract 781).

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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-pd-impact-on-orthostatic-hypotension-during-dose-optimization/