The Committee for Medicinal Products for Human Use ( CHMP ), following a re-examination procedure, adopted a positive opinion for the medicinal product Sialanar, intended for the symptomatic treatment of severe sialorrhoea ( chronic pathological drooling ).
Sialanar is available as a 320 micrograms/ml oral solution of Glycopyrronium ( 400 micrograms/ml Glycopyrronium bromide ).
The active substance of Sialanar is Glycopyrronium bromide.
Glycopyrronium bromide is a quaternary ammonium antimuscarinic with peripheral effects similar to those of Atropine. The peripheral antimuscarinic effect leads to a decreased production of secretions from the salivary glands.
The benefits with Sialanar are its ability to reduce salivary secretions shown in an improvement on mTDS ( Modified Teacher's Drooling Scale ) as well as in investigator and caregiver global assessment.
The most common side effects are anticholinergic adverse reactions related to the gastrointestinal system such as dry mouth, constipation, diarrhoea and vomiting, all of which occurred at a rate of greater than or equal to 15% in placebo controlled trials. Other side effects related to the anticholinergic effects, which occurred at a rate of greater than or equal to 15%, include urinary retention, flushing and nasal congestion.
The full indication is: symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders.
Due to limited long term safety data, the treatment duration should be kept as short as possible and closely monitored. ( Xagena )
Source: EMA, 2016