CHMP recommends a change to the existing indication for Slentyo (melatonin prolonged release) to include children with neurogenetic disorders

Slenyto is a child appropriate prolonged release melatonin formulation that was approved in the EU in 2018 for the treatment of insomnia in children with autism spectrum disorder (ASD) and/ or Smith-Magenis Syndrome. Slenyto is the only authorised medication for insomnia in these disorders.

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 (ASD) 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 NGDs, 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," said Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals.

Paul Gringras, Professor of paediatric Sleep Medicine, London, England commented: "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".

About Insomnia in children with neurogenetic disorders (NGD's): Sleep impairment is a common comorbidity in neurogenetic disorders, with up to 86% of children reported to experience disrupted sleep, starting at an early age. During early childhood, sleep plays an essential role in healthy cognitive and psychosocial brain development, influencing learning memory, emotional regulation, and brain structure. Children with neurogenetic disorders tend to develop insomnia and other sleep disorders at an early age. Insomnia has a significant impact on these children, aggravating disease symptoms and reducing quality of life in both patients and caregivers.

Current practices recommend parent-directed behavioral sleep interventions as first-line treatment for pediatric insomnia in NGDs, with a 25% response rate. Slenyto will be the first approved pharmacological treatment for insomnia in children and adolescents with NGDs.