The following is a summary of “Long-term safety, tolerability and efficacy of apomorphine sublingual film in patients with Parkinson’s disease complicated by OFF episodes: a phase 3, open-label study,” published in the March 2024 issue of Neurology by Kassubek et al.
Researchers conducted a retrospective study examining the safety, tolerability, and effectiveness of apomorphine sublingual film (SL-APO) used for at least three years in patients with Parkinson’s disease (PD).
They conducted Study CTH-301 (September 3, 2015), a phase 3, multicentre, open-label trial of SL-APO in patients with PD with motor fluctuations. It included a dose-titration and long-term safety phase where all participants were administered SL-APO. The primary focus was on safety/tolerability (measured by treatment-emergent adverse events [TEAEs]) during the long-term safety phase. Efficacy was assessed using the Movement Disorder Society-Unified PD Rating Scale (MDS-UPDRS) part III (motor examination) at weeks 24, 36, and 48 within the first year of the long-term safety phase.
The results showed that of 496 patients, 120 (24.2%) completed the long-term safety phase. The mean duration of SL-APO exposure was 294.3 days. About 65.3% of patients experienced TEAEs related to the study drug, with the most common being nausea (6.0%), stomatitis (1.8%), lip swelling (1.8%), dizziness (1.6%), oral mucosal erythema (1.6%), and mouth ulceration (1.6%). TEAEs leading to study drug withdrawal were reported by 34.0% of patients, with the most common being nausea (5.4%), lip swelling (4.5%), mouth ulceration (2.6%), and stomatitis (2.3%). A clinically significant decrease in MDS-UPDRS part III score occurred 15 minutes after SL-APO intake, peaking at around 30 minutes and lasting up to 90 minutes post-dose. The effect remained stable throughout the 48 weeks.
Investigators concluded that SL-APO was safe, effective, and well-tolerated for long-term use in treating OFF episodes for patients with PD.
Source: link.springer.com/article/10.1007/s00415-024-12323-2
