TEL AVIV, Israel, March 26, 2025 /PRNewswire/ -- Neurim Pharmaceuticals ("Neurim") announces that the European Commission has approved the extension of the indication to include the treatment of insomnia in children with attention deficit hyperactivity disorder (ADHD). The European Commission decision followed the recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025. 

Slenyto® is a child-appropriate prolonged release melatonin formulation that was first approved in the EU in 2018 for the treatment of insomnia in children with autism spectrum disorder (ASD) and/ or Smith-Magenis Syndrome. In 2024, the indication was extended to neurogenetic disorders (NGDs).  Slenyto® is the only authorised medication for insomnia in these disorders.

The adopted wording for the newly extended indication is:

"Slenyto® is indicated for the treatment of insomnia:

1. 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
2. In children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient

"We recognise there is significant unmet need and high demand for addressing sleep maintenance and duration as well as sleep initiation difficulties of children with ADHD, who suffer from impaired sleep. The European Commission (EC) granted marketing authorization (MA) of Slenyto^® for insomnia in children with ADHD is a major move to satisfy this need." says Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals. 

Prof. Carmen Schroder, MD, PhD, France, and Prof. Oliviero Bruni, MD, PhD, Italy, comment: " 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 the population of children with neurodevelopmental disorders, among which ADHD, improving sleep latency, sleep continuity and total nighttime sleep duration, in particular in those who do not produce sufficient endogenous melatonin. Slenyto® has been specifically formulated for use in children and has a favorable safety profile. Subsequent improvements in child behavior (mainly due to longer uninterrupted sleep), parent satisfaction and quality of life (mainly affected by the child's behavior) are expected. The treatment will address a significant need in the medical management of many children and adolescents with ADHD".

ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Sleep impairment is a common comorbidity in ADHD, with up to 70% of children reported to experience disrupted sleep, starting at an early age.  Sleep duration and the number of nighttime awakenings in children with ADHD differ from those of typically developing children from a very young age – often before formal ADHD diagnosis.  Co-occurring sleep problems in children with ADHD have been shown to predict more severe core symptoms, exacerbate daytime sleepiness, and reduce quality of life in both patients and caregivers.

Current practices recommend parent-directed behavioral sleep interventions as first-line treatment for pediatric insomnia in ADHD. Slenyto® is a unique pharmacological treatment for insomnia in children and adolescents with ADHD that would address not only sleep initiation but also sleep maintenance and sleep duration disorders.

ABOUT SLENYTO^®

Slenyto^® is an age-appropriate prolonged-release formulation of melatonin, a hormone involved in the regulation of the circadian clock and sleep. The mini-tablet's innovative formulation was specifically designed to facilitate ease of swallowing without resistance in pediatric ASD, NGD and ADHD populations, in response to the unmet need in the field of paediatric insomnia.

Slenyto® delivers melatonin over the night to mimic the endogenous melatonin release profile in healthy subjects. In Phase III study in ASD and SMS children and adolescents, with and without ADHD, 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 improvement in parents' well-being. Analysis of Slenyto effect on the primary endpoint, total sleep time, demonstrated the same level of improvement in participants with and without ADHD comorbidity.

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 neurodevelopmental 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.

Neurim has a strong and innovative product pipeline targeting central nervous system (CNS) disorders.

Contact: Guy Manor, VP Commercial Operations, [email protected]