- Prevalence of Autism Spectrum Disorder (ASD) among children and youth aged 1 to 17 years, is about 2% (1 in 50) and is equivalent to about 150,000 cases in Canada in 2025 [1, 2]. Smith-Magenis syndrome (SMS) is a very rare (1:15,000 to 1:25,000 births) genetic neurodevelopmental disorder that affects behaviors, emotions and learning processes and roughly 300–500 children in Canada aged 1–17 may have SMS in 2025 [2, 3].
- Between 50-80% of children with ASD & SMS suffer from insomnia, much more than typically developing children [4]. Sleep disturbances can negatively impact components of executive function, such as intellectual development and behavioural regulation [5].
MISSISSAUGA, ON, Jan. 13, 2026 /PRNewswire/ - Kye Pharmaceuticals ("Kye"), a Canadian specialty pharmaceutical company based in Mississauga, Ontario, today announced that it has entered into a licensing and distribution agreement with Neurim Pharmaceuticals ("Neurim"), an international neuroscience drug discovery pharmaceutical company, for SLENYTO® (Extended -release melatonin) in Canada.
SLENYTO® is the first and only prescription extended-release melatonin developed specifically for the treatment of insomnia in children and adolescents with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS) and was granted marketing authorization by Health Canada on September 8th, 2025 [6, 7, 8]. SLENYTO® has been approved in multiple international markets, such as Germany, France and the UK, among others, and represents a significant advancement in addressing sleep disturbances, a highly prevalent and impactful comorbidity in children with ASD/SMS [9].
Under the terms of the agreement, Kye Pharmaceuticals will be responsible for the regulatory, commercialization, and distribution activities for SLENYTO® in Canada.
"This agreement is fully aligned with Kye's mission to bring differentiated, clinically meaningful therapies to patients in Canada with high unmet medical needs," said John McKendry, President of Kye Pharmaceuticals. "Sleep disorders and insomnia in particular place a substantial burden on children with autism and their families, and SLENYTO® offers a well-studied, prescription-grade, child appropriate extended-release option designed specifically for this population. We are proud to partner with Neurim to introduce this important therapy to Canadian patients."
Neurim developed SLENYTO® based on its proprietary extended-release melatonin technology and deep expertise in circadian rhythm and sleep disorders.
"We are very pleased to partner with Kye Pharmaceuticals to bring SLENYTO®, a first-in-class pediatric treatment for insomnia, addressing an unmet need for ASD and SMS patients across Canada," said Prof. Nava Zisapel, Founder and Chief Scientific Officer at Neurim Pharmaceuticals. "It is the only melatonin-based treatment developed specifically for children with neurodevelopmental disorders, offering a safe and effective solution that improves both sleep and daytime functioning. We believe collaborating with Kye and their strong focus on specialty care, and expertise in the pediatric neurodevelopmental field are a great match for Neurim, in our mission to improve the lives of patients affected by sleep disorders worldwide."
About SLENYTO®
SLENYTO® is a prescription only child appropriate prolonged/extended-release melatonin formulation designed to mimic the body's natural melatonin secretion profile throughout the night. It has been clinically evaluated and proven effective and safe in pediatric patients with ASD/SMS and sleep disorders and is approved in multiple jurisdictions outside Canada. www.slenyto.com
About Kye Pharmaceuticals
Kye Pharmaceuticals is a Canadian specialty pharmaceutical company based in Mississauga, Ontario, focused on licensing and commercializing innovative prescription therapies that are not otherwise available to patients across Canada. Kye's portfolio spans a range of therapeutic areas including neurology, psychiatry, pediatrics, rare diseases, hematology, cardiology and neuromuscular disorders. Kye partners with global pharmaceutical and biotechnology companies to license and launch medicines that matter, and deliver better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. www.kyepharma.com
About Neurim Pharmaceuticals
Neurim Pharmaceuticals Ltd. is a neuroscience drug discovery and development company. Its first approved drug, CIRCADIN®, is approved for patients over the age of 55 who are suffering from insomnia and is commercially available in 45 countries around the world.
Neurim has a strong and innovative product pipeline targeting central nervous system (CNS) disorders. www.neurim.com
References:
[1] Autism spectrum disorder: Highlights from the 2019 Canadian health survey on children and youth. Public Health Agency of Canada Publication, (February, 2022): Link. |
[2] Statistics Canada Data Sources used to calculate number of children and youths in Canada between 1 and 17 in 2025: Canada's population clock (real-time model), [Accessed on December 29th, 2025]: Link & Population estimates on July 1, by age and gender, [Accessed on December 29th, 2025]: Link |
[3] Smith ACM, Berens J, Boyd KE, Brennan C, Gropman A, Haas-Givler B, Vlangos C, Foster R, Franciskovich R, Girirajan S, Raitano Lee N, Taylor C, Turnacioglu SO, Elsea SH. Smith-Magenis Syndrome. In: Adam MP, Bick S, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2025. Initial posting 2001 Oct 22; last update 2025 May 29. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1310/ |
[4] Lai MC, Kassee C, Besney R, Bonato S, Hull L, Mandy W, Szatmari P, Ameis SH. Prevalence of co-occurring mental health diagnoses in the autism population: a systematic review and meta-analysis. Lancet Psychiatry. 2019 Oct;6(10):819-829. doi: 10.1016/S2215-0366(19)30289-5. |
[5] Tesfaye R, Wright N, Zaidman-Zait A, Bedford R, Zwaigenbaum L, Kerns CM, Duku E, Mirenda P, Bennett T, Georgiades S, Smith IM, Vaillancourt T, Pickles A, Szatmari P, Elsabbagh M. Investigating longitudinal associations between parent reported sleep in early childhood and teacher reported executive functioning in school-aged children with autism. Sleep. 2021 Sep 13;44(9):zsab122. doi: 10.1093/sleep/zsab122. |
[6] Neurim Press Release: "Health Canada Approves Slenyto® - Extended-Release Melatonin Formulation - as a Prescription Drug for Insomnia in Children with Autism Spectrum disorder and Smith Magenis Syndrome", (Sep 10, 2025): Link |
[7] Health Canada - Regulatory Decision Summary for Slenyto, (Sep 08, 2025): Link & Health Canada Notice of amendment: Addition of melatonin to the Prescription Drug List, (Sep 09, 2025): Link |
[8] Health Canada Product Monograph for Slenyto: https://pdf.hres.ca/dpd_pm/00081654.PDF |
[9] Slenyto product webpage: www.slenyto.com |
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SOURCE Kye Pharmaceuticals Inc.
