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
Kassubek, Jan (German Centre for Neurodegenerative Diseases (Bonn, Alemanya))
Factor, Stewart A. (Emory University School of Medicine)
Balaguer, Ernest (Hospital Universitari General de Catalunya)
Schwarz, Johannes (Kreisklinik Ebersberg)
Ray Chaudhuri, Kallol (King's College London)
Isaacson, Stuart H. (Parkinson's Disease and Movement Disorders Center of Boca Raton)
Wu, Stacy (Sumitomo Pharma America. Inc.)
Denecke Muhr, Carmen (BIAL-Portela & amp; Ca S.A.)
Kulisevsky, Jaime (Institut de Recerca Sant Pau)

Data:	2024
Resum:	Apomorphine sublingual film (SL-APO) is an on-demand treatment for OFF episodes in patients with Parkinson's disease (PD). To assess the long-term (≥ 3 years) safety/tolerability and efficacy of SL-APO. Methods: Study CTH-301 (http://www. clinicaltrials. gov NCT02542696; registered 2015-09-03) was a phase 3, multicentre, open-label study of SL-APO in PD patients with motor fluctuations, comprised of a dose-titration and long-term safety phase. All participants received SL-APO. The primary endpoint was safety/tolerability (treatment-emergent adverse events [TEAEs]) during the long-term safety phase. Efficacy assessments included the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination), assessed at weeks 24, 36 and 48 during the first year of the long-term safety phase. 496 patients were included and 120 (24. 2%) completed the long-term safety phase. Mean duration of SL-APO exposure was 294. 3 days. TEAEs related to study drug were experienced by 65. 3% of patients (most common: nausea [6. 0%], stomatitis [1. 8%], lip swelling [1. 8%], dizziness [1. 6%], oral mucosal erythema [1. 6%], mouth ulceration [1. 6%]). TEAEs leading to study drug withdrawal were experienced by 34. 0% of patients (most common: nausea [5. 4%], lip swelling [4. 5%], mouth ulceration [2. 6%], stomatitis [2. 3%]). A clinically meaningful reduction in MDS-UPDRS part III score was observed as soon as 15 min following administration of SL-APO, with peak effects observed approximately 30 min post-dose and sustained up to 90 min post-dose; results were consistent over 48 weeks. SL-APO was generally well tolerated and efficacious over the long term as an on-demand treatment for OFF episodes in patients with PD.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Apomorphine sublingual film ; Motor fluctuations ; OFF episodes ; Parkinson's disease
Publicat a:	Journal of neurology, Vol. 271 Núm. 6 (june 2024) , p. 3554-3570, ISSN 1432-1459

DOI: 10.1007/s00415-024-12323-2
PMID: 38546829

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