Objective: Assess impact of apomorphine sublingual film (APL) on time spent with and functional impact of dyskinesia among patients with Parkinson’s disease (PD) and “OFF” episodes.

Background: In a 12-wk pivotal study, APL was efficacious and generally well tolerated for on-demand treatment of “OFF” episodes in patients with PD. However, dopaminergic agents have been associated with dyskinesia.

Method: An ongoing, open-label, Phase 3 study (NCT02542696) to evaluate the long-term safety (LTS) and efficacy of APL enrolled patients with PD (new or rollover from prior Phase 2/3 studies) and “OFF” episodes on stable PD medications. APL dose titration occurred in patients who were “OFF” to determine the effective and tolerable dose (10–35 mg; 5-mg increments) that converted them to FULL “ON” within 45 min. In the LTS phase, patients self-administered their titrated APL dose for up to 5 “OFF” episodes/d. Dyskinesia was assessed using MDS-UPDRS Part IV. Results were summarized descriptively and assessed at wks 24, 36, and 48. TEAEs of dyskinesia were also evaluated.

Results: This analysis (data cut 30Sep2020) evaluated 397 patients (median [range] exposure to APL was 169 [1–1181] d; 1.8 mean doses/d; highest dose received in the LTS phase, 10/15/20/25/30/35 mg: 18%/23%/23%/18%/11%/7%). From baseline of 12.00 (16.88), mean (SD) percent time with dyskinesia decreased by –1.10 (21.45), –1.99 (19.58), and –3.93 (19.03) at wks 24, 36, and 48, respectively. Severity of time spent with dyskinesia (percent of waking day) was normal to mild in 96% of patients at baseline and 98%, 99%, and 99% at wks 24, 36, and 48, respectively. More patients reported “Improved” or “No change” vs “Worsening” for change from baseline in time spent with dyskinesia at wks 24 (83% vs 17%), 36 (84% vs 16%), and 48 (83% vs 17%), and functional impact of dyskinesia at wks 24 (83% vs 17%), 36 (87% vs 13%), and 48 (83% vs 17%).These findings are consistent with the low adverse event rate for dyskinesia reported in 6% of patients in the LTS phase.

Conclusion: Apomorphine sublingual film as an on-demand treatment for “OFF” episodes in patients with PD resulted in reduced time spent with dyskinesia and higher rates of “Improved” or “No change” vs “Worsening” of dyskinesia for up to 48 wks in the long-term study. Data suggest that repeated and chronic use of APL is not associated with the development or worsening of dyskinesia.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-parkinsons-disease-impact-on-dyskinesia/