The SALIVA study protocol
This press release is intended to provide investors with an update on the ongoing SALIVA study
The SALIVA (Sialanar® plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) study protocol published
In May 2021, the first child was recruited into the SALIVA study, a trial sponsored by Proveca Pharma Ltd.
The SALIVA study is a double-blind randomised controlled trial comparing Sialanar® (glycopyrronium bromide) against placebo. The SALIVA study was designed to evaluate the efficacy and safety of a paediatric specific oral solution of glycopyrronium along with its impact on quality of life.1 The study is now complete and the protocol has been published in the BMJ Paediatrics Open:https://bmjpaedsopen.bmj.com/content/7/1/e001913.
Recruitment for the study is now complete with a total of 87 children. Final results are expected by the end of 2023. Findings will be presented at conferences and published in peer-reviewed journals.
Full product information on Sialanar® can be found here: https://www.medicines.org.uk/emc/product/2301 .
About Proveca
Proveca is a European pharmaceutical company which specialises in the development and licensing medicines, to address 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.
Reference
- BMJ Paediatric Open. 2023 May; 7 (1) . Protocol of the SALIVA trial [online] Available at:https://bmjpaedsopen.bmj.com/content/7/1/e001913. Accessed: May 2023.
INT-SIA-23-0009
Created May 2023