Kye Pharmaceuticals and Neurim Pharmaceuticals Team Up for SLENYTO® Launch in Canada

Kye Pharmaceuticals Partners with Neurim for SLENYTO® Distribution in Canada

Kye Pharmaceuticals, a specialty pharmaceutical company based in Mississauga, Ontario, has recently announced an exciting collaboration with Neurim Pharmaceuticals for the exclusive licensing and distribution of SLENYTO® in Canada. This agreement marks a significant step forward in addressing the critical issue of insomnia among children with Autism Spectrum Disorder (ASD) and Smith-Magenis Syndrome (SMS).

As per the latest studies, the prevalence of Autism Spectrum Disorder among Canadian youth aged 1 to 17 years stands at approximately 2%, equating to around 150,000 affected individuals. Additionally, sleep disorders, particularly insomnia, are a common comorbidity among these children, with up to 80% suffering from sleep disturbances that impact their overall well-being and executive functioning.

SLENYTO® is renowned as the first prescription extended-release melatonin specifically designed for pediatric use in managing insomnia related to ASD and SMS. This novel therapy received marketing authorization from Health Canada on September 8, 2025, and is already available in markets including Germany, France, and the UK. The unique formulation of SLENYTO® aims to mimic the body's natural melatonin secretion, providing a safe and effective solution for these vulnerable populations.

Under the new licensing arrangement, Kye Pharmaceuticals will oversee all regulatory compliance, commercialization strategies, and distribution processes for SLENYTO® within Canada. John McKendry, President of Kye Pharmaceuticals, expressed that this partnership aligns perfectly with the company's mission to deliver clinically significant therapies to populations that have unmet medical needs. He emphasized the burden that sleep disorders impose not only on children with autism but also on their families, highlighting SLENYTO® as a well-researched, prescription-grade option tailored for this demographic.

Neurim Pharmaceuticals, a pioneer in neuroscience and drug development, boasts a solid track record with its innovative melatonin technology. Professor Nava Zisapel, Chief Scientific Officer at Neurim, stated their enthusiasm about collaborating with Kye Pharmaceuticals. They aim to fill the treatment gap for children suffering from insomnia due to neurodevelopmental disorders across Canada, leveraging Kye’s extensive expertise in pediatric care and specialty pharmaceuticals.

The introduction of SLENYTO® is poised to facilitate a remarkable improvement in sleep patterns among children grappling with ASD and SMS, thereby enhancing their daily functioning and quality of life. As studies indicate, effective treatment of sleep disturbances plays a crucial role in supporting overall cognitive and behavioral development in these children.

This collaborative effort holds a vital promise for families affected by sleep challenges, providing a specialized treatment option that addresses the unique needs of children with neurodevelopmental disorders. As the launch of SLENYTO® approaches, stakeholders within the healthcare community, as well as families of affected children, eagerly anticipate the positive impact this drug will have.

For more information on SLENYTO® and its availability, stakeholders can visit the product's official website at www.slenyto.com, or Kye Pharmaceuticals's informative platform at www.kyepharma.com. Through such partnerships and innovations, the pharmaceutical industry strives to make significant strides in improving healthcare solutions for those who need it most.