Objective: This study evaluated the efficacy of apomorphine sublingual film (SL-APO) in elderly (≥70 years) and younger (<70 years) patients over the long term.

Background: SL-APO is indicated for the on-demand treatment of OFF-episodes in patients with Parkinson’s disease (PD). Its efficacy was demonstrated in several clinical trials with Study CTH-301 showing its long-term clinical benefits.

Method: The Phase 3, multicentre, non-randomised, open-label Study CTH-301 assessed the long-term (≥3 years) safety, tolerability and efficacy of SL-APO. This post-hoc analysis evaluated the efficacy of SL-APO in patients aged <70 and ≥70 years. Assessments included SL-APO dose, discontinuation rate due to lack of efficacy, changes in Movement Disorder Society-Unified PD Rating Scale (MDS-UPDRS) Part III scores from pre- to post-dose at Weeks 24, 36 and 48, and percentage of patients with a full-ON response within 30 minutes post-dose at Weeks 24, 36 and 48.

Results: Of the 369 de novo (not previously exposed to SL-APO) patients included in Study CTH-301, 253 (68.6%) were aged <70 years and 116 (31.4%) ≥70 years. The mean SL-APO optimised dose was similar for the <70 and the ≥70 years age groups (19.6 mg vs 21.2 mg; p=0.09). Both groups achieved a clinically meaningful reduction in MDS-UPDRS Part III at all time points [figure1]. More than 75% of patients in both groups reported a full-ON response at all visits [figure2]. The rate of discontinuation due to lack of efficacy was low and comparable across age groups (6.3% [16/253] vs 6.0% [7/116]).

Conclusion: SL-APO was efficacious over the long-term as an on-demand treatment for OFF episodes in elderly patients with PD.

Figure 1.

Figure 2.

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-films-efficacy-in-elderly-patients-with-parkinsons-disease-post-hoc-analysis-of-study-cth-301/