#Canada #Toronto #Autism #Slenyto® #Insomnia

Big News in Pediatric Sleep Medicine

Health Canada has recently made a significant advancement in pediatric healthcare by approving Slenyto®, the first extended-release melatonin formulation specifically designed for children and adolescents suffering from insomnia associated with Autism Spectrum Disorder (ASD) and Smith-Magenis Syndrome (SMS). This milestone, announced by Neurim Pharmaceuticals, provides a much-needed treatment option for a vulnerable population.

Why This Approval Matters

Sleep disorders are prevalent among children with ASD, impacting as many as 80% of this demographic. The struggle with sleep not only hinders the quality of life for these children, but it also exacerbates their behavioral and cognitive challenges, creating a challenging environment for families. With conventional sleep hygiene methods often falling short, the introduction of Slenyto® represents a beacon of hope for parents and caregivers.

Understanding Slenyto®

Slenyto® is a small, child-friendly minitablet measuring only 3mm in diameter and is designed to release melatonin, a hormone that naturally regulates the sleep-wake cycle. Unlike over-the-counter melatonin supplements, Slenyto® effectively mimics the body’s natural release pattern of this hormone, aiming to improve both the onset of sleep and the quality of sleep throughout the night.

The formulation is particularly advantageous for children who might face challenges with traditional pills, as it is odorless, tasteless, and easy to swallow, catering to those with sensory sensitivities or difficulties in swallowing. It should be administered once a day, 30 to 60 minutes before bedtime, and must be swallowed whole.

Clinical Evidence of Efficacy

Clinical trials evaluating Slenyto® have been robust, involving a randomized, double-blind, placebo-controlled setup. The results have shown remarkable improvements in

• - Sleep latency: The time taken to fall asleep
• - Total sleep time: Overall duration of sleep
• - Sleep continuity: Duration of uninterrupted sleep
• - Daytime behavior: Overall daytime functioning and mood

These benefits were sustained over extended use, showcasing not only effectiveness but also a favorable safety profile with limited adverse effects.

Expert Opinions

Various experts in the pediatric and sleep medicine fields have lauded Slenyto® as a game-changer for managing insomnia among children with ASD and SMS.

Prof. Nava Zisapel, Chief Scientist at Neurim Pharmaceuticals, expressed pride in launching this unique solution in Canada, emphasizing its potential to fill a significant gap in pediatric care for these disorders.

Dr. Shelly Weiss, a renowned Pediatric Neurologist and sleep expert, highlighted Slenyto® as a “paradigm shift” in managing insomnia in ASD, emphasizing its tailored dosage adjustments and excellent tolerability.

This approval not only promises to address immediate issues related to sleep but also holds the potential to enhance the overall quality of life for these children and their families.

What’s Next?

Slenyto® is anticipated to be accessible soon, listed in the Prescription Drug List (PDL) for Canada, and will be available through pediatric specialists, sleep clinics, and pharmacies across the country. Neurim Pharmaceuticals is committed to ensuring that healthcare providers and families have the educational support necessary for effective implementation of this new treatment.

About Neurim Pharmaceuticals

Neurim is a distinguished neuroscience company dedicated to the discovery and development of innovative drugs targeting central nervous system disorders. With a promising pipeline and a history of successful launches, including CIRCADIN® for older adults, Neurim continues its mission to advance treatments that significantly improve patient outcomes.

In conclusion, Slenyto®'s approval in Canada marks a key moment in the identification and management of sleep disorders among children affected by developmental conditions. As families gain access to this new treatment, we can expect a meaningful improvement in sleep quality and daily living for children confronting these challenges.