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

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. 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