Proveca Receives Positive CHMP Opinion for Sialanar® (Glycopyrronium) Orodispersible Tablets (ODT), Expanding Choice in the Management of Severe Sialorrhoea
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Proveca Receives Positive CHMP Opinion for Sialanar® (Glycopyrronium) Orodispersible Tablets (ODT), Expanding Choice in the Management of Severe Sialorrhoea
Positive opinion supports an innovative, orodispersible tablet formulation designed to provide an additional licensed treatment option for children affected by severe sialorrhoea.
Proveca has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Sialanar® orodispersible tablets (ODT) for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. The EMA CHMP opinion is a recommendation to the European Commission (EC), which is responsible for the final decision on this change to the Sialanar® ODT marketing authorisation. A decision from the EC is anticipated by the end of September 2026.
The positive CHMP opinion marks a significant milestone for Proveca and represents an important lifecycle extension for the established Sialanar® franchise.
Sialanar® ODT has been developed as an innovative, child-friendly formulation. Utilising Zydis® orodispersible technology, the tablet rapidly dissolves in the mouth and is designed to offer a convenient administration option for patients, families and healthcare professionals.
This is aligned with a wider global ambition to make medicines more suitable for children. The World Health Organisation has recognised the importance of flexible solid dosage forms, including orodispersible tablets, in improving access to age-appropriate paediatric medicines.
Sialanar® ODT expands the range of licensed treatment options available for children and families managing severe sialorrhoea. Recognising that no single formulation meets the needs of every patient, the availability of both an oral solution and an orodispersible tablet enables healthcare professionals to choose the most appropriate option based on an individual patients’ circumstances, treatment stage and preference.
Dr Simon Bryson, co-founder and Chief Executive Officer of Proveca, commented:
“This positive CHMP opinion marks a significant achievement for Proveca and reflects our continued commitment to developing medicines designed specifically for children.
Sialanar® ODT will expand the licensed treatment options available for severe sialorrhoea, providing healthcare professionals with an additional licensed formulation for use where clinically appropriate, subject to EC decision”
Severe sialorrhoea can be a persistent and distressing symptom for children living with chronic neurological conditions. It can affect comfort, communication, skin health, social participation, and quality of life, while also placing a significant practical and emotional burden on parents/caregivers. Providing licensed, age-appropriate treatment options is therefore an important part of supporting patient-centered care for children and families affected by this condition.
Following the positive CHMP opinion, the European Commission is expected to issue a final marketing authorisation decision later this year.
About Sialanar® ODT
Sialanar® ODT (Prescription Only Medicine) is an orodispersible tablet formulation containing glycopyrronium, developed for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. The product utilises Zydis® orodispersible technology and has been designed to dissolve rapidly in the mouth, providing an additional licensed treatment format for patients, parents/caregivers and healthcare professionals. Adverse reactions are common with glycopyrronium due to its known pharmacodynamic anticholinergic effects. During a 9 month trial, the most common adverse reactions were constipation (29.7%), dry mouth (10.8%), irritability (5.4%), psychomotor hyperactivity (5.4%) and urinary retention (2.7%).
About Proveca
Proveca is a specialty pharmaceutical company focused on the development, licensing and commercialisation of evidence-based medicines that address the significant unmet medical needs in children. The Company develops age-appropriate formulations and paediatric-specific medicines designed to improve treatment outcomes, adherence, and quality of care. Proveca’s portfolio spans multiple therapeutic areas, including neurology and cardiology, and is supported through a global network of regulatory, commercial and development partners.
For more information, visit: www.proveca.com
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Email: info@proveca.com
References
- Sialanar® 320 micrograms/ml oral solution. Summary of Product Characteristics. Proveca Pharma Limited. Available via the European Medicines Agency product information page. Accessed July 2026.
- European Medicines Agency. Sialanar®: European public assessment report (EPAR). Accessed July 2026.
- World Health Organization. Development of paediatric medicines: points to consider in formulation. WHO Technical Report Series, No. 970, Annex 5.
- Orubu ESF, Tuleu C. Medicines for children: flexible solid oral formulations. Bulletin of the World Health Organization. 2017;95(3):238–240. doi:10.2471/BLT.16.171967.
- World Health Organization. Driving access to better paediatric medicines on World Children’s Day. 20 November 2023.
- Data on file
Sialanar® is a registered trademark of Proveca Limited.
August 2026 INT-SIA-26-0011