Clinical Evidence

Study design ^1,2

• Double-blind, randomised, phase IV clinical trial comparing Sialanar® with placebo, in addition to continued oral rehabilitation for 12 weeks (n=87)¹
• Continued open-label study extension (OLSE) for 24 weeks - all children received Sialanar® (n=74)² 
• Children aged 3-17 years with chronic neurodisabilities and:^1,2
  • Severe sialorrhoea (≥6 on the modified Teachers Drooling Scale) 
  • And ≥ 50 Drooling Impact Scale (DIS) score

Primary endpoints^1,2

• Blinded-phase: Change in DIS score between baseline and week 12 (day 84)
• OLSE: Change in DIS between baseline and week 36, and the DIS change between
  12 weeks and 36 weeks.

Secondary endpoints: efficacy, safety and QoL including:^1,2

• Change in DIS score between baseline and day 28
• Proportion of responders (DIS improvement ≥ 13.6 points) at days 28 and 84 (12 weeks) and day 252 (36 weeks)
• Proportion of good responders (DIS improvement ≥ 28 points) at day 84 (12 weeks) and day 252 (36 weeks)
• Change from baseline in the number of bibs or clothing used (DIS item 3) at day 28 and 84 (12 weeks)
• Incidence of adverse events from baseline (day 0) through week 36, including the titration phase (day 0 to week 4), maintenance phase (weeks 4-12),¹ and open-label extension period (weeks 12-36)²

Sialanar^® provides significantly greater DIS improvements from baseline vs placebo at week 12 (median: -29.5 vs -1; p<0.001)¹ with sustained improvements in DIS from baseline to week 36 (p<0.001)²

• Early and significant improvements in DIS score versus baseline after 4 weeks (p<0.01) & 12 weeks (p<0.001)¹
• Significant sustained improvement in DIS at 36 weeks (p<0.001)²
• Patients that continued treatment ith Sialanar at week 12 showed a median 39-point DIS reduction at 36 weeks vs baseline, which is classed as a 'very good to excellent improvement' according to the carer's global rating of change.³
• Patients that switched from placebo to Sialanar^® treatment at week 12 showed -34.0 median change in DIS at 36 weeks vs baseline, classed as 'highly significant'. (p<0.001)²
• Over 70% of patients were good responders (≥28 point improvement) on the DIS across the entire 36-week period

Sialanar® is effective at reducing the impact of drooling on the child's and family's day-to-day life vs placebo at 12 weeks¹

• Sialanar^® significantly improved drooling and reduced its impact on quality of life versus placebo²
• The impact of drooling on the child's and family's lives was reduced with Sialanar^® treatment over the 36- week period^1,2
• Between week 12 and 36, patients who received Sialanar^® during the blinded phase continued to show numerical reductions in the DIS related to the impact of drooling on the child's and family's lives.²
• The impact of drooling on the lives of children and their families was significantly reduced when children were switched from placebo to Sialanar^® at week 12²

Bib and clothing changes:

• Sialanar^® treatment significantly reduced the median number of bibs/clothes used per day at 12 weeks vs. placebo¹
• • Helping to reduce costs
  • enabling more time for carers to focus on other areas of care
  • reducing the impact of drooling on the child's and family's QoL

Sialanar® was well tolerated throughout the 36-week SALIVA study^1,2 with fewer side effects after dose-titration²

Sialanar^® had fewer treatment-related AEs after initial dose-titration and overall good tolerability²

The most frequent treatment-related adverse events (occurring in ≥ 2 children [5%] in any treatment arm) were constipation and dry mouth.