Glycopyrronium bromide (trade name: Sialanar) has been approved in Germany since September 2016 for the treatment of pathological drooling (sialorrhea) in children over the age of three and teenagers with chronic neurological conditions.
Chronic sialorrhea is a neurological condition in which saliva can no longer be swallowed or too much saliva is produced. In addition to causing emotional distress, excessive drooling can lead to problems such as chronic skin infections around the mouth, coughing, choking, and vomiting.
Glycopyrronium bromide aims to decrease the production of saliva in the salivary glands.
The drug is available as a solution to be taken three times a day, either an hour before or two hours after a meal. The dose is based on the patient’s body weight and occurrence of side effects. The treatment should be reassessed at least every three months. It is also recommended that the medication only be used for short periods of time with breaks in between. This is because there is no data on its long-term safety.
Best supportive care (BSC) is an alternative option for children and teenagers with chronic pathological drooling. This treatment should be tailored to the patient's individual needs, with the aim of relieving symptoms and improving quality of life. It includes things like swallowing therapy.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of glycopyrronium bromide compared with best supportive care for the treatment of severe drooling in children or teenagers with a chronic neurological condition.
But the manufacturer did not provide any suitable data with which to do the assessment.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of glycopyrronium bromide (Sialanar).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Glycopyrronium bromide (sialorrhoea) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-22. June 27, 2018. (IQWiG reports; Volume 640).
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