Neurim Pharmaceuticals (“Neurim”) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending an extension to the existing indication to include the treatment of Insomnia in children with Neurogenetic disorders (NGDs).
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”.
