Clinical Evidence

Study Design¹

• A double-blind, randomised, clinical phase IV trial comparing Sialanar® with placebo, in addition to continued oral rehabilitation.
• 87 children (3-17 years) with neurodisabilities and severe sialorrhoea (modified Teachers Drooling Scale ≥6) were randomised 1:1 to Sialanar® or placebo, in addition to non-pharmacological standard care during a 3-month double-blinded period.
• The dose was titrated over a period of up to 4 weeks.

Sialanar® provides significantly greater Drooling Impact Score improvements vs placebo at day 84 (median: -29.5 vs -1; p<0.001)¹

• Early improvement in DIS after 4 weeks (p<0.001)¹ vs placebo 
• Significant improvement in DIS at 12 weeks (p<0.001)¹ vs placebo

Sialanar® is effective at reducing the impact of drooling on the child's and family's day-to-day life vs placebo at 12 weeks ¹

Sialanar® was well tolerated throughout the 12-week SALIVA study¹

^{The most common treatment-related adverse event in both treatment arms was constipation (20.5% for Sialanar® vs 16.3% for placebo).}