#Israel #Tel Aviv #ADHD #Neurim Pharmaceuticals #Slenyto®

Neurim Pharmaceuticals Secures European Marketing Authorization for Slenyto®

Neurim Pharmaceuticals, based in Tel Aviv, has announced the successful acquisition of marketing authorization from the European Commission for Slenyto®, a prolonged-release melatonin formulation aimed at treating insomnia in children diagnosed with attention deficit hyperactivity disorder (ADHD). This significant approval follows the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommendation earlier this year.

Initially approved in 2018 for treating insomnia in children with autism spectrum disorder (ASD) and Smith-Magenis Syndrome, Slenyto® has now expanded its indications to include children aged 6 to 17 with ADHD. The formulation is uniquely designed for children, ensuring safety and efficacy, making it the only authorized treatment for insomnia associated with these neurodevelopmental conditions.

Understanding Slenyto®

Slenyto® is specifically engineered to closely mimic the natural release of melatonin in healthy individuals. Its prolonged-release formula provides melatonin throughout the night, hence addressing sleep maintenance, sleep initiation, and the overall duration of sleep disturbances seen in children with ADHD.

Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals, emphasized the critical unmet need for effective insomnia treatments in young patients with ADHD. With sleep difficulties significantly impacting these children's daily lives, Slenyto®'s approval represents a crucial advancement in the landscape of pediatric sleep aids.

Furthermore, studies suggest that addressing sleep shortages positively influences child behavior, thereby enhancing the quality of life for both the affected children and their families. Parents often report improved satisfaction stemming from better child behavior, which correlates with the quality and duration of sleep provided by treatments like Slenyto®.

The Challenge of Insomnia in ADHD

Sleep disturbances are commonly seen in children with ADHD, with estimates indicating that up to 70% of these children face various sleep-related challenges. These issues often occur even before an official ADHD diagnosis. Research highlights that co-occurring sleep problems can worsen ADHD symptoms, limit daytime functionality, and degrade overall quality of life for both children and their caregivers.

Presently, behavioral interventions directed by parents are recommended as the initial approach to managing pediatric insomnia related to ADHD. However, the introduction of Slenyto® provides a new pharmacological option that specifically targets sleep disturbances, underlining a significant progression in treatment methodologies.

The Mechanism Behind Slenyto®

The mini-tablet formulation of Slenyto® simplifies administration for young patients—a crucial factor amidst pediatric populations often resistant to oral medications. Additionally, clinical trials demonstrate that Slenyto® effectively improves critical sleep parameters across various age groups and underlying neurodevelopmental disorders. Through its action on sleep latency and restfulness, the treatment aims to normalize sleep conditions akin to those of typically developing youngsters.

Neurim Pharmaceuticals' commitment extends beyond Slenyto® as the company continues to develop innovative solutions targeting central nervous system (CNS) disorders. With their existing product CIRCADIN® already available globally for older patients experiencing insomnia, Neurim positions itself as a robust player in advancing therapies that enhance sleep quality across various demographics.

In conclusion, with the European Commission's endorsement, Neurim Pharmaceuticals not only reinforces its standing within the pharmaceutical arena but also paves the way for addressing the pressing sleep needs of children grappling with ADHD. As countless families await effective solutions to manage these sleep-related challenges, Slenyto® stands as a beacon of hope towards improving the overall health and well-being of affected children.