SLENYTO is Recently Available in Canada As a Prescription Treatment for Insomnia in Children and Adolescents with Autism Spectrum Disorder (ASD) and Smith-Magenis Syndrome (SMS).

SLENYTO is the first and only prescription melatonin in Canada and the only melatonin authorized for sale by Health Canada for children and adolescents 2 to <18 years of age. Autism Spectrum Disorder affects approximately 1 in 44 (2.25%) Canadian children and youth; 60-86% of children with ASD experience sleep irregularities.

Kye Pharmaceuticals, Inc. announced that SLENYTO is now available across Canada. SLENYTO is approved as a prescription medication in Canada for the management of insomnia in children and adolescents aged 2 to <18 years with autism spectrum disorder (ASD) and Smith-Magenis syndrome (SMS), where sleep hygiene events have been inadequate.

SLENYTO was clinically assessed and demonstrated both safety and effectiveness in pediatric patients with insomnia related to ASD and SMS, conditions which are characterized by disrupted melatonin secretion or an inverted circadian rhythm. SLENYTO received a Notice of Compliance from Health Canada.

"We are proud to bring the first and only prescription melatonin therapy with a purpose-designed pediatric formulation for this patient population to Canada", said Julian Oliver, Commercial Lead, General Medicines & Business Operations, Kye Pharmaceuticals. "SLENYTO® addresses a significant unmet need for children and adolescents with insomnia and ASD and/or SMS, as well as their families and the physicians who care for them."

SLENYTO is a protracted-release melatonin formulation designed to mimic the natural nighttime secretion of melatonin. It is obtainable as a pediatric-appropriate odourless, tasteless 3mm mini-tablet. The effectiveness, safety, and tolerability of SLENYTO have been established via a 13-week placebo-controlled clinical trial and a 91-week open-label period to assess properties of long-term application in children and adolescents.

"In my practice, I see a high variability in how families select, dose, or benefit from a multitude of over-the-counter melatonin health supplements to support sleep." Said Dr. Shelly Weiss, Professor, Pediatric Neurologist, SickKids, University of Toronto, Pediatric Sleep Expert, and previous President of the Canadian Sleep Society. "SLENYTO® gives clinicians the first extended-release option specifically developed, studied, and approved for children with autism spectrum disorder in Canada."

SLENYTO is recently available by prescription via pharmacies in Canada.

According to Towards Healthcare, the circadian rhythm sleep disorder market is projected to grow significantly, with estimates indicating the market size will increase from USD 2.65 billion in 2026 to approximately USD 4.69 billion by 2035. The market is expanding at a CAGR of 6.56% between 2026 and 2035.Treatment aims to enhance sleep quality, attentiveness, and performance at work and general quality of life. Though symptomatic management is required during the course of adaptation to shift work, the ideal strategy is to ensure good sleep hygiene and to realign circadian rhythms with the work schedule. Suitable alignment of circadian rhythms enhances sleep quality, increases awareness and performance during safety, and shift.

About Smith-Magenis Syndrome

Smith-Magenis Syndrome (SMS) is a rare genetic disorder caused by a deletion or mutation including the RAI1 gene on chromosome 17, characterized by distinctive physical characteristics, developmental delay, and a recognizable cluster of behavioural traits, involving self-injurious behaviors, aggression, and repetitive movements. Sleep disturbance is one of the most prominent features of this phenotype, largely driven by an inverted circadian rhythm. Rather than increasing at night as it normally does, melatonin peaks during the day, disrupting the sleep-wake cycle and contributing to frequent nighttime awakenings, early morning awakenings, and extreme daytime sleepiness.

About SLENYTO

SLENYTO is the only prescription melatonin in Canada. It is a patented extended-release melatonin available in a pediatric-appropriate 3mm mini-tablet.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals is focused on the discovery and development of advanced novel therapeutics for disorders related to the central nervous system (CNS). With a proven track record of drug advancement and commercialization, Neurim's first products, Circadin and Slenyto, are in use in more than 40 countries across 5 continents. Continuously expanding into additional therapeutic regions, the R&D pipeline comprises novel products that address sleep and neurodevelopmental disorders.

About Kye Pharmaceuticals Inc.

Kye is a growth-stage Canadian specialty pharmaceutical organization, headquartered in Toronto, committed to bringing value to Canadians by identifying, licensing, and commercializing new prescription therapeutics that are not otherwise available to patients in Canada. With an increasing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas involving neurology, psychiatry, pediatrics, rare diseases, hematology, cardiology, and neuromuscular diseases.

A recent report by Towards Healthcare highlights that the circadian rhythm sleep disorder market is growing, as multiple genes control circadian rhythms and are responsible for a different of significant functions, including daily fluctuations in wakefulness, body temperature, metabolism, digestion, and hunger. Circadian rhythm controls memory consolidation; the formation of long-term memories occurs during sleep; the timing of hormone secretion the hormones controlling body growth work mostly at night); and body healing. The circadian sleep phase generally occurs at night; there is a range of times during which the sleep phase occurs, with some patients programmed to sleep from early evening to early morning, while others stay up late and sleep late.