Objective: We explored tremor outcomes associated with apomorphine sublingual film (SL‑APO) in patients with a tremor‑dominant PD phenotype.
Background: Tremor is a common and disabling feature of Parkinson’s disease (PD) that frequently responds suboptimally to oral dopaminergic therapy. SL-APO is an on-demand formulation approved for the acute, intermittent treatment of OFF episodes in levodopa-responsive PD and was developed to offer rapid onset of effect with non-invasive administration [1].
Method: Post‑hoc analyses were conducted using data from a 12‑week randomized, double‑blind, placebo‑controlled trial (NCT02469090) and a 12‑month open‑label study (NCT02542696) of SL‑APO in levodopa‑responsive patients with PD and OFF episodes. Tremor‑dominant phenotype was defined according to Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS‑UPDRS) criteria. Tremor severity was assessed using a tremor index derived from MDS‑UPDRS items.
Results: In the randomized trial, 31/108 patients (28.7%) met criteria for tremor‑dominant PD. At Week 12, greater reductions in tremor index scores were observed at 30 minutes post‑intake in patients receiving SL‑APO compared with placebo (mean change −5.3 vs −1.1 points), corresponding to an exploratory between‑group difference of −4.4 points (p<0.001). The standardized effect size was large (Cohen’s d −1.83). Clinically meaningful improvement, defined using a distribution‑based threshold, occurred more frequently in the SL‑APO group (80%) than with placebo (30%), yielding an estimated number needed to treat of 1.3. Median time‑to‑ON with SL‑APO was 13.0 minutes. In the open‑label study, tremor reductions of 31–37% were observed over 12 months, with responder proportions remaining above 70%.
Conclusion: In this post‑hoc analysis, SL‑APO was associated with rapid tremor improvement in patients with tremor‑dominant PD. The large effect size suggests potential relevance, though findings are exploratory and require prospective confirmation.
References: [1] Kassubek J, Jost WH, Schwarz J. Sublingual apomorphine in the treatment of Parkinson’s disease. J Neural Transm (Vienna). 2024 131: 1209-1216.
To cite this abstract in AMA style:
H. S Dafsari, J. Reis, K. Strauß, H. C Brigas, C. Denecke-Muhr, I. Pijuan Jiménez, J. Holenz. Sublingual apomorphine for parkinsonian tremor: Post-hoc analysis of pivotal trial data [abstract]. Mov Disord. 2026; 41 (suppl 1). https://www.mdsabstracts.org/abstract/sublingual-apomorphine-for-parkinsonian-tremor-post-hoc-analysis-of-pivotal-trial-data/. Accessed October 1, 2026.« Back to 2026 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/sublingual-apomorphine-for-parkinsonian-tremor-post-hoc-analysis-of-pivotal-trial-data/