The European Medicines Agency’s CHMP recommended expanding the use of a melatonin-based treatment to help children with neurogenetic disorders manage insomnia.
RT’s Three Key Takeaways
- Extended Use Recommendation: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Slenyto, a prolonged-release melatonin drug, to treat insomnia in children with neurogenetic disorders, broadening its initial approval for autism spectrum disorder and Smith-Magenis Syndrome.
- Targeted Treatment: Slenyto is designed to improve sleep latency, continuity, and duration in children by mimicking the natural melatonin release profile.
- Addressing Unmet Needs: Upon approval, Slenyto will be the only authorized medication for sleep disorders in children with neurogenetic disorders.
Neurim Pharmaceuticals has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending the extension of Slenyto’s use to treat insomnia in children with neurogenetic disorders.
Slenyto is a child-appropriate, prolonged-release melatonin formulation that was approved in the European Union in 2018 for the treatment of insomnia in children with autism spectrum disorder and/or Smith-Magenis Syndrome.
The adopted recommended wording for the extended indication is: “Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder and/or neurogenetic disorders with aberrant diurnal melatonin secretion and/or nocturnal awakenings, where sleep hygiene measures have been insufficient.”
“The positive CHMP opinion on Slenyto represents a significant milestone in addressing an unmet need for children with [neurogenetic disorders], who suffer severely from impaired sleep. Upon approval, Slenyto would be the only medicinal product approved for sleep disorders in this unique paediatric population, allowing treatment initiation at an early age,” says Nava Zisapel, CEO of Neurim Pharmaceuticals, in a release.
Paul Gringras, professor of pediatric Sleep Medicine at King’s College London, comments in a release: “Melatonin deficiency or misalignment is a common pathophysiological mechanism for insomnia in neurogenetic disorders. Slenyto is a prolonged-release formulation of melatonin that delivers melatonin over the course of the night, mimicking the endogenous release profile in healthy subjects. Therefore, Slenyto has the potential to treat the pathophysiology of insomnia in this population improving sleep latency, sleep continuity and total nighttime sleep duration. Slenyto has been specifically formulated for use in children and has a favorable safety profile. The treatment will address a significant need in the medical management of many children and adolescents with NGDs”.
Neurim Pharmaceuticals’ first approved drug, Circadin, is approved for patients over the age of 55 with insomnia and is commercially available in 45 countries, including Europe, Asia-Pacific, Latin America, Africa, and the Middle East.
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