European Commission grants extension of marketing authorisation for Sialanar® (glycopyrronium) to include orodispersible tablets, expanding treatment choice

This press release is intended for investors only

Proveca Pharma Ltd is delighted to announce that, on 25 September 2026, the European Commission granted an amendment to the Sialanar^® (glycopyrronium) marketing authorisation to include orodispersible tablets. The decision follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 23 July 2026.^[1,2]

Sialanar^® orodispersible tablets, a prescription-only medicine, are indicated for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. The orodispersible tablets are available in two strengths, 0.68 mg and 1.36 mg glycopyrronium. They are placed on the tongue or in the buccal cavity and allowed to disperse without water.

Sialanar^® orodispersible tablets have been developed as an innovative, child-friendly formulation. Utilising Catalent’s Zydis® orodispersible tablet technology, the tablet rapidly dissolves in the mouth and is designed to offer a convenient administration option for patients, families and healthcare professionals.^[5]

This orodispersible tablet presentation is aligned with a wider global ambition to make medicines more suitable for children. The World Health Organization has recognised the importance of flexible solid oral dosage forms, including orodispersible tablets, as part of efforts to improve access to age-appropriate paediatric medicines. By rapidly dissolving in the mouth, Sialanar^® orodispersible tablets offer the convenience of a tablet without requiring children to swallow a conventional solid dosage form.^[3,4]

Beyond convenience, the orodispersible tablets expand 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 liquid solution and an orodispersible tablet enables healthcare professionals, patients and caregivers to choose the most appropriate option based on individual circumstances, treatment stage and patient preference.

The oral solution supports dose titration, while suitable patients may switch to the corresponding tablet strength once a stable and effective dose has been established.

Severe Sialorrhoea can be a persistent and distressing symptom for children living with chronic neurological disorders. It can affect comfort, communication, skin health, social participation and quality of life, while creating a significant practical burden for families and caregivers.

Dr Simon Bryson, CEO, Proveca, said: “The approval of Sialanar^® orodispersible tablets is an important milestone for Proveca and, more importantly, broadens the licensed treatment choices available to children and families managing severe drooling. No single formulation will meet every patient’s needs. By adding an option that disperses in the mouth without water, we can support healthcare professionals and families in choosing a formulation that better fits the individual child and everyday life.”

Dr Helen Shaw, Co-Founder, Proveca, said: “Children with chronic neurological disorders can face significant challenges when taking medicines, and those practical difficulties can also affect parents and caregivers. This additional formulation has been developed around those real-world needs. It reflects Proveca’s continued focus on age-appropriate medicines that give children, families and healthcare professionals meaningful choice.”

About severe Sialorrhoea

Sialorrhoea (chronic pathological drooling) is the unintentional loss of saliva from the mouth due to impaired oral motor control and swallowing function, commonly associated with neurological disorders Severe sialorrhoea can affect comfort, communication, skin health, social participation and quality of life, and requires appropriate clinical assessment and management.^[1]

Glycopyrronium belongs to the drug class called anticholinergics, which are used in the treatment of severe Sialorrhoea. They act on muscarinic receptors in the salivary glands and reduce the production of saliva.^[1]

About Sialanar^® orodispersible tablets;

Contain glycopyrronium and are available in 0.68 mg and 1.36 mg strengths. ^[1]

Adverse reactions are common with glycopyrronium due to its known pharmacodynamic anticholinergic effects. The most common adverse reactions are dry mouth (11 %), constipation (20 %), diarrhoea (18 %), vomiting (18 %), urinary retention (15 %), flushing (11 %) and nasal congestion (11 %). Adverse reactions are more common with higher doses and prolonged use.

Before prescribing healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information, including contraindications, warnings, precautions and the complete safety profile.^[1]

About Proveca

Proveca is a pharmaceutical company with technical and commercial operations globally. The company specialises in the development, licensing and commercialisation of evidence-based medicines designed to address the unmet medical needs of children, with a paediatric product portfolio across neurology and cardiology.

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Proveca Pharma Ltd.
2 Dublin Landings,
North Wall Quay,
Dublin 1,
D01 V4A3
Ireland