Sialanar® (glycopyrronium bromide) is licensed for the symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders1

The SALIVA Trial - the first and only double-blind, randomised, placebo-controlled study in sialorrhoea, that has investigated efficacy, tolerability and quality of life.2

 

Discover the topline results on this page or download the publication below.

The SALIVA trial demonstrated Sialanar® significantly improves drooling and its impact on quality-of-life, with good tolerability vs placebo2
Study Design2

Study Design

  • 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 (participants are then invited into a 6-month, open-label study extension period).
  • The dose was titrated over a period of up to 4 weeks.
  • Primary endpoint: the change from baseline to day 84 in the Drooling Impact Scale (DIS) score.
  • Secondary endpoints: efficacy,* safety and QoL including responders (DIS improvement ≥ 13.6 points), good responders (DIS improvement ≥ 28 points) and overall changes in DIS - endpoints were assessed at varying time points respectively.

*The efficacy endpoints were assessed in a hierarchal sequence.

Study Method

 

Efficacy - Sialanar® significantly improves drooling vs placebo2

Sialanar® provides significantly greater Drooling Impact Score improvements vs placebo at day 84 (median: -29.5 vs -1; p<0.001)2

Change in DIS score between baseline and D84

Sialanar® significantly reduced bibs/clothing usage vs placebo2

Change in score for DIS Item 3

A significant reduction in the median number of bibs/clothes used per day was seen with Sialanar® (-3) compared to placebo (0) from baseline to day 84, helping to reduce costs and enabling more time for carers to focus on other areas of care.2

QoL - Sialanar® significantly reduces the impact of drooling on quality of life vs placebo2

Sialanar® is effective at reducing the impact of drooling on the child's and family's day-to-day life vs placebo2

Score for DIS Item 9 & 10

Tolerability - Sialanar® is well tolerated2

The most common treatment-related adverse event in both treatment arms was constipation (20.5% for Sialanar vs 16.3% for placebo)2

Treatment-related adverse events

Interested in discussing the data in more detail?

 Submit the form to arrange a discussion on the SALIVA trial with the Proveca team.

Resources

Visit the resources section to find product support materials for patients/carers and educational resources for healthcare professionals.
Resources

References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 – accessed April 2024
  2. Fayoux P et al., Glycopyrronium 320 μg/mL in children and adolescents with severe sialorrhoea and neurodisabilities: A randomized, double-blind, placebo-controlled trial. Developmental Medicine & Child Neurology 2024; 00: 1–9. DOI: 10.1111/dmcn.15841. https://onlinelibrary.wiley.com/doi/10.1111/dmcn.15841  - accessed April 2024

UK-SIA-24-0015 | April 2024

Reporting of side effects

UK
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Republic of Ireland
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. Adverse event should be reported, reporting forms and information can be found at: www.hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects should also be reported to Proveca Limited. Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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UK-SIA-23-0102 | August 2023