Neurim Pharmaceuticals Gains EU Approval for Pediatric Melatonin

Neurim Pharmaceuticals Gains European Marketing Authorization

Neurim Pharmaceuticals has announced a significant milestone in addressing pediatric sleep disorders with the European Commission's recent approval for extending its product, Slenyto®, for the treatment of insomnia in children diagnosed with attention deficit hyperactivity disorder (ADHD). This development provides new hope for families dealing with the challenges associated with sleep disturbances in children with ADHD.

What is Slenyto®?

Slenyto® is a specially formulated prolonged-release version of melatonin designed for children, initially approved in Europe in 2018 to treat insomnia in children with autism spectrum disorder (ASD) and/or Smith-Magenis Syndrome. The medication was already recognized for its efficacy in other neurogenetic disorders since its indication was expanded in 2024. The recent marketing authorization further solidifies its position as a pivotal option for treating insomnia in children with ADHD, where conventional sleep hygiene practices fall short.

Extended Indications

The newly articulated indications for Slenyto® address two crucial pediatric groups:

1. Children and adolescents aged 2-18 with autism spectrum disorder (ASD) and/or neurogenetic disorders characterized by disrupted melatonin secretion and nocturnal awakenings, where standard sleep hygiene methods have proven ineffective.
2. Children and adolescents aged 6-17 years with ADHD exhibiting similar difficulties when conventional non-pharmacological approaches insufficiently manage their insomnia.

Understanding the Impact of ADHD on Sleep

The connection between ADHD and sleep difficulties cannot be overstated. Studies suggest that up to 70% of children with ADHD experience sleep disruptions, frequently starting well before a formal ADHD diagnosis. Poor sleep quality negatively affects not only the child's well-being but also leads to increased daytime sleepiness and reduced quality of life for both the child and their caregivers.

Behavioral Recommendations for Sleep Issues

Current clinical guidelines suggest that the first step in managing pediatric insomnia within ADHD contexts involves behavioral interventions led by parents. However, Slenyto® stands out as a unique pharmacological solution that addresses both sleep initiation and maintenance challenges, signifying a new era of treatment options for these children.

About Slenyto® and its Mechanism

Slenyto® is more than just a melatonin medication; it's an innovative formulation that mimics the body’s natural release of melatonin throughout the night. The goal is to help children achieve the necessary sleep at night, which in turn helps improve their daily function and behavior. Clinical studies have shown that this treatment leads to enhancements in sleep latency (the time it takes to fall asleep), sleep continuity, and overall sleep duration.

Scientific Support

Prominent medical professionals have voiced their support for Slenyto®, emphasizing its potential to address sleep disorders in children with ADHD while altering their overall health trajectory. Improved sleep patterns are anticipated to lead to better behavior, greater parental satisfaction, and enhanced quality of life for families.

The Importance of Proper Sleep Management in ADHD

Proper sleep management is essential for children with ADHD. As many experience sleep problems at a young age, it is vital to address these issues to reduce core symptoms and improve overall functioning. The introduction of Slenyto® fits into this narrative, providing a pharmaceutical solution where previous treatments have failed.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals Ltd. is dedicated to developing innovative neuroscience drugs, with its first successful drug, CIRCADIN®, already approved for patients over 55 with insomnia and available in 45 countries. The company continues to progress its product lineup, targeting various central nervous system disorders and demonstrating a commitment to addressing significant medical needs in populations often overlooked.

Frequently Asked Questions

What is Slenyto® used for?

Slenyto® is a melatonin-based medication approved for treating insomnia in children and adolescents, particularly those with ADHD and neurodevelopmental disorders.

Who can benefit from Slenyto®?

Children aged 2 to 18 with ASD, neurogenetic disorders, or ADHD, who are experiencing significant sleep issues may benefit from this treatment.

How does Slenyto® work?

Slenyto® mimics the natural release pattern of melatonin in the body, promoting better sleep onset, continuity, and duration throughout the night.

Is Slenyto® safe for children?

Yes, Slenyto® has been formulated specifically for children, and clinical studies have demonstrated its favorable safety profile when used under medical supervision.

Who can I contact for more information about Neurim Pharmaceuticals?

For inquiries about Neurim Pharmaceuticals and its products, please reach out to Guy Manor, VP of Commercial Operations, for assistance.

About The Author

Hello, I'm 30-year-old financial writer and expert Addison Perry, and I love to simplify the intricacies of the financial industry. I've committed myself over the years to deciphering the subtleties of investing techniques and economic trends and converting them into doable guidance that anybody can use. My goal with writings and books is to make money interesting and approachable so that readers may take charge of their financial futures.

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