TEL-AVIV, Israel, July 30, 2024 /PRNewswire/ -- 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".
ABOUT INSOMNIA IN CHILDREN WITH NEUROGENETIC DISORDERS (NGDs)
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.
ABOUT SLENYTO®
Slenyto® is an age-appropriate prolonged-release formulation of melatonin, a hormone involved in the regulation of circadian clock and sleep. The mini-tablet innovative formulation was specifically designed to facilitate ease of swallowing without resistance in pediatric ASD and NGD population, in response to the unmet medical need in the field of paediatric insomnia.
Slenyto® delivers melatonin over the night to mimic the endogenous melatonin release profile in healthy subjects. In a Phase III study in ASD and SMS children and adolescents, Slenyto® improved sleep latency, sleep continuity and total nighttime sleep duration. The positive effect on sleep maintenance and duration was associated with an improvement in externalizing behavior, which correlated with an improvement in parents' well-being.
The mechanism of action of Slenyto® on sleep latency, sleep maintenance and total sleep time is independent of the background disorder. Therefore, any patient with a neurogenetic disorder with sleep disturbances associated with aberrant diurnal melatonin secretion patterns and/or insufficient nighttime melatonin secretion will benefit from Slenyto®.
ABOUT NEURIM PHARMACEUTICALS
Neurim Pharmaceuticals Ltd. (www.neurim.com) is a neuroscience drug discovery and development company. Its first approved drug, CIRCADIN®, is approved for patients over the age of 55 who are suffering from insomnia and is commercially available in 45 countries around the world, including Europe, Asia-Pacific, Latin America, Africa and the Middle East.
Neurim has a strong and innovative product pipeline targeting central nervous system (CNS) disorders.
Contact:
Guy Manor
VP Commercial Operations