What is Sialanar - Glycopyrronium bromide used for?
Sialanar is a severe medicine for the treatment of sialorrhoea (excessive saliva secretion) in children and adolescents (aged 3 years or older) with neurological diseases, such as cerebral palsy, epilepsy and neurodegenerative diseases. It contains the active ingredient glycopyrronium bromide.
How is Sialanar - Glycopyrronium bromide used?
Sialanar is available as a solution to be taken orally three times a day, one hour before or two hours after meals. The initial dose depends on the patient's body weight. The dose is then adjusted according to how the patient responds to the medicine and its side effects.
Sialanar should be prescribed by a doctor who has experience in treating children with neurological conditions and can only be obtained with a prescription.
How does Sialanar - Glycopyrronium bromide work?
The active ingredient in Sialanar, glycopyrronium bromide, blocks receptors found in the salivary glands called muscarinic receptors. These receptors trigger saliva production when they are activated by the nerves of the brain. By blocking the receptors, the medicine should help reduce the amount of saliva produced by the glands and therefore reduce sialorrhea.
What benefit has Sialanar - Glycopyrronium bromide shown during the studies?
Based on two published studies, glycopyrronium bromide is effective in reducing sialorrhea in children and adolescents with neurological diseases, using a standard assessment scale known as mTDS (where a score of 1 means no sialorrhea and a score of 9 means profuse sialorrhea ).
In one of the studies, conducted on 38 children and adolescents suffering from severe sialorrhea, after 8 weeks a decrease in the score of 3 points or more was observed in about 74% of subjects treated with glycopyrronium bromide, compared to 18% of those treated with placebo (a dummy treatment).
The second study involved 27 children and adolescents with severe sialorrhea, who took glycopyrronium bromide or placebo for 8 weeks and whose treatment was subsequently reversed for another 8 weeks. This study focused on the mean final scores for sialorrhea after 8 weeks of treatment, equal to 1.9 for patients treated with glycopyrronium bromide and 6.3 for patients treated with placebo.
What are the risks associated with Sialanar - Glycopyrronium bromide?
The most common side effects of Sialanar (which may affect more than 1 in 10 patients) are irritability, hot flushes, a stuffy nose, reduced airway secretions, dry mouth, constipation, diarrhea, vomiting and an inability to completely empty the bladder (urinary retention). For the full list of all side effects reported with Sialanar, see the package leaflet.
Sialanar should not be used in patients with glaucoma (an eye condition), urinary retention, severe renal dysfunction or a history of certain intestinal diseases or myasthenia gravis (a condition that affects the muscles). It must also not be used in patients who are pregnant or who are taking potassium chloride tablets or capsules or medicines that have an anticholinergic effect. For the full list of Sialanar limitations, see the package leaflet.
Why has Sialanar - Glycopyrronium bromide been approved?
The use of glycopyrronium bromide is well established in the EU as a treatment for sialorrhea and published studies show that it is effective in the treatment of severe sialorrhea in children and adolescents with neurological diseases that can affect their quality of life. Regarding the risks, the side effects that occur with glycopyrronium bromide can be managed through adequate monitoring of patients and by adjusting the dose.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Sialanar's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Sialanar - Glycopyrronium bromide?
To help physicians and patients who help patients use the medicine as safely as possible, the company that markets Sialanar will provide them with material containing information on how to use the medicine and manage side effects correctly.
Recommendations and precautions to be followed by healthcare professionals and patients for Sialanar to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Sialanar - Glycopyrronium bromide
For the full EPAR for Sialanar, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Sialanar therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
