Glycopyrronium 320 mug/mL in children and adolescents with severe sialorrhoea and neurodisabilities: An open-label study extension of the SALIVA trial.

AIMS: To test the long-term efficacy, safety, and impact on quality of life (QoL) of an oral paediatric formulation of 320 mug/mL glycopyrronium in the 36-week SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial. METHOD: In the initial 12-week blinded period, 87 children with neurodisabilities and severe sialorrhoea were randomized to 320 mug/mL glycopyrronium versus placebo. In the subsequent 24-week open-label study extension, 74 children received 320 mug/mL glycopyrronium (37 continued glycopyrronium, 37 switched from placebo). RESULTS: The open-label study extension population included 39 males and 35 females. The median age was 10 years 2 months (quartile 1, quartile 3: 7 years 5 months, 14 years 7 months; range: 3 years 5 months-17 years 8 months). Over 36 weeks, continued 320 mug/mL glycopyrronium resulted in a median 39-point reduction in Drooling Impact Scale (DIS) score from baseline (quartile 1, quartile 3: -51, -21; p < 0.001), with an 81.1% response rate (DIS improvement >/= 13.6 points) and a 70.3% good response rate (>/= 28 points). Improvements in the impact of drooling on QoL seen in the blinded period were sustained with continued glycopyrronium. Treatment-related adverse events occurred most frequently during titration (0-4 weeks: 40.9%; 5-20 weeks: 32.4% in those who switched). Constipation was the most common adverse event. INTERPRETATION: Long-term treatment with 320 mug/mL glycopyrronium resulted in significant sustained improvements in drooling and QoL, with fewer adverse events after initial titration and overall good tolerability.