Health Canada Approves Groundbreaking Melatonin for Pediatric Insomnia
Health Canada's Approval of Slenyto® Marks a Milestone in Pediatric Care
Neurim Pharmaceuticals is thrilled to announce that Health Canada has granted marketing authorization for Slenyto®, a unique extended-release melatonin minitablet designed specifically to treat insomnia in children aged 2 to under 18 years with Autism Spectrum Disorder (ASD) or Smith-Magenis syndrome (SMS). This approval signifies a significant advancement in pediatric sleep medicine, addressing a critical need for effective treatment where traditional sleep hygiene practices have failed.
Understanding the Need for Slenyto®
Sleep disorders are prevalent among children with ASD, with estimates suggesting that up to 80% face challenges in obtaining adequate rest. These issues can contribute to heightened behavioral problems and cognitive difficulties, resulting in considerable anxiety and stress for families. Slenyto® stands out as the first pharmacotherapy explicitly developed for this demographic, offering a solution that is not only clinically proven but also well-received by children.
What is Slenyto®?
Slenyto® is an extended-release oral minitablet, designed with a diameter of just 3mm, making it suitable for children. It incorporates melatonin, a natural hormone that plays a vital role in regulating sleep-wake patterns. Uniquely, Slenyto® aims to replicate the body's natural rhythm of melatonin release, thereby enhancing both the onset of sleep and its maintenance throughout the night.
Key Features of Slenyto®
The formulation of Slenyto® is tasteless and odorless, and it is designed for easy swallowing, catering particularly to children with sensory sensitivities or difficulties. The recommended use is a single dose taken 30 to 60 minutes before bedtime, with the necessity to swallow the minitablets whole without chewing or crushing them.
Clinical Evidence Supporting Slenyto®
In rigorous clinical evaluations, including randomized, double-blind, placebo-controlled trials, Slenyto® has shown significant improvements in several key areas for children diagnosed with ASD or SMS:
- Sleep latency: Reduction in time taken to fall asleep.
- Total sleep time: An increase in the total duration of sleep.
- Sleep continuity: Enhanced duration of uninterrupted sleep.
- Daytime behavior: Marked improvements in daytime mood and behavior.
The long-term benefits of Slenyto® usage have demonstrated a favorable safety profile with minimal reported side effects.
Indications and Usage of Slenyto®
Approved for use, Slenyto® is indicated specifically for the treatment of insomnia in children and adolescents from ages 2 to under 18 with ASD or SMS, where other measures have proven ineffective.
Transforming Pediatric Sleep Care Standards
According to Prof. Nava Zisapel, Founder and Chief Scientist at Neurim Pharmaceuticals, "Slenyto® represents a significant stride in addressing the unmet medical needs of children suffering from insomnia associated with neurodevelopmental conditions." This approval ushers in a first-in-class therapeutic option that prioritizes safety and effectiveness, promising enhancements in both sleep quality and overall daily functioning.
Additionally, Dr. Shelly Weiss, a renowned Pediatric Neurologist and Sleep Expert, emphasizes the importance of this treatment: "The outcomes from pivotal studies highlight the substantial improvements in sleep quality and daytime moods. Slenyto® significantly enhances the quality of life for children with ASD, which in turn benefits their families as well. This medication is set to become an essential part of managing sleep issues in pediatric patients with ASD."
Availability of Slenyto® in Canada
Parents and caregivers can expect to see Slenyto® listed in the Prescription Drug List (PDL) shortly. It will be accessible through pediatric specialists, sleep clinics, and pharmacies across the nation. Neurim Pharmaceuticals is dedicated to ensuring widespread availability along with providing necessary educational resources and support for healthcare providers and parents alike.
About Neurim Pharmaceuticals
Neurim Pharmaceuticals Ltd. is a trailblazer in the field of neuroscience, specializing in drug discovery and development. Their portfolio includes CIRCADIN®, an established treatment for insomnia, which has gained approval in over 45 countries. Neurim remains committed to delivering innovative solutions that target central nervous system disorders, enhancing the lives of patients worldwide.
Frequently Asked Questions
What is Slenyto® used for?
Slenyto® is prescribed for treating insomnia in children aged 2 to under 18 diagnosed with Autism Spectrum Disorder or Smith-Magenis syndrome, particularly when other methods have failed.
How does Slenyto® work?
Slenyto® mimics the body’s natural release of melatonin, effectively helping children to fall asleep and stay asleep throughout the night.
Is Slenyto® suitable for all children?
Slenyto® is specifically formulated for children with ASD or SMS, making it a tailored solution for those with unique sleep-related challenges.
What are the side effects of Slenyto®?
Clinical trials have shown that Slenyto® has a favorable safety profile, with minimal adverse effects reported during studies.
When will Slenyto® be available in Canada?
Slenyto® is expected to be available shortly through pediatric specialists and pharmacies, following its listing in the Prescription Drug List.
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