The SALIVA trial publication

This press release is intended for investors only.


Publication of the SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) Study

On the 12th January 2024,  the SALIVA study was published online in the Journal of Developmental Medicine and Child Neurology. The first and only double-blind, randomised, placebo controlled study for glycopyrronium bromide in sialorrhoea, that has investigated efficacy, tolerability and the impact on quality of life.

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This study is very important for Proveca as it provides direct clinical evidence on Sialanar® (320mcg/ml glycopyrronium). This will help with market development/expansion, especially in those countries which need specific product data.

Glycopyrronium 320 micrograms/mL in children and adolescents with severe sialorrhoea and neurodisabilities: A randomised, double-blind, placebo-controlled trial.

The oral 320 micrograms/mL glycopyrronium (Sialanar®) formulation was compared with placebo in a 3-month double-blind, randomised trial which was conducted in 13 French centres; these centres specialise in treating childhood neurodisabilities or children with ENT issues. All patients who completed the initial 3-month double-blinded period were then invited to receive Sialanar® in a 6-month open-label study extension – this is now complete. The protocol was approved by an independent ethics committee and the French Agence Nationale de Sécurité du Médicament.

“Drooling is a common and distressing condition in children with chronic neurological disorders which deeply impacts the quality of life for patients, parents and carers and is also associated with respiratory illnesses and complications in the case of posterior sialorrhoea. The SALIVA study not only looks at efficacy and safety but also the impact on quality of life is considered for the first time in such a study” said Prof Fayoux, ENT surgeon at Lille University Hospital, the trial’s lead investigator.

“The SALIVA study is a great milestone for Proveca and adds to the evidence we have on Sialanar®, reinforcing it’s value in the management of drooling.  We hope this study will help healthcare professionals understand the need to manage severe drooling and therefore provide a positive impact on the quality of life for their patients and the families as seen in the study.  This new published data is important to enable more patients to access Sialanar®, particularly in those markets where further product specific information is required.” said Simon Bryson, CEO, Proveca Pharma Ltd.


Full product information on Sialanar® (Prescription Only Medicine) can be found here:®#product-information-section

Results showed that Sialanar® was generally well tolerated and no new safety concerns were identified. The most frequent treatment-related adverse events were constipation (20.5%), dry mouth (6.8%) and vomiting (6.8%).


About Proveca

Proveca is a European pharmaceutical company who specialises in the development and licensing of medicines to address the unmet medical needs for children.

Working with clinicians, parents, carers and children, Proveca are leading the way to provide licensed medicines that are tailored to children’s specific requirements.



EU Clinical Trials Register, EudraCT Number: 2020-005534-15 Available at:

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Created February 2024