Neurim Pharmaceuticals News
6 articles
growth-positive
/CNW/ -- Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorization* for Slenyto®, an Extended-release melatonin...
Neurim Pharmaceuticals has received marketing authorization from Health Canada for Slenyto®, an extended-release melatonin minitablet designed for treating insomnia in children and adolescents with Autism Spectrum Disorder (ASD) and Smith-Magenis syndrome (SMS). This approval marks a significant advancement in pediatric sleep medicine in Canada, addressing a critical unmet need for this population. Slenyto® is the first pharmacotherapy specifically developed and clinically tested for insomnia in children with these conditions. The product has demonstrated significant improvements in sleep latency, total sleep time, and sleep continuity, with a favorable safety profile. Neurim Pharmaceuticals aims to ensure broad access to Slenyto® across Canada through pediatric specialists, sleep clinics, and pharmacies.
Product StageFDA approved/pending approval
growth-positive
/PRNewswire/ -- Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorization* for Slenyto®, an Extended-release...
Neurim Pharmaceuticals has received marketing authorization from Health Canada for Slenyto®, an extended-release melatonin minitablet designed to treat insomnia in children and adolescents with Autism Spectrum Disorder (ASD) and Smith-Magenis syndrome (SMS). This approval marks a significant advancement in pediatric sleep medicine, offering a clinically proven and well-tolerated treatment for children with ASD affected by chronic sleep disturbances. Slenyto® is the first pharmacotherapy specifically developed and approved for insomnia in this population, addressing a critical unmet medical need. The product will soon be available in Canada through pediatric specialists, sleep clinics, and pharmacies.
Product StageFDA approved/pending approval
N/A
Melatonin may ease autistic children's sleep troubles
A new study suggests that melatonin is safe for long-term use in autistic children who have difficulty sleeping. The study tracked the effects of melatonin on autistic children over a two-year period and found that it can improve sleep and overall quality of life. The study also addressed concerns about the hormones long-term safety, particularly in regard to puberty, and found that melatonin does not interfere with puberty. The study adds to the growing evidence that melatonin is safe and effective for children with autism. However, it is important to have a regulated version of melatonin in the U.S. that is backed by data, as the current over-the-counter supplements vary in quality and dosage.
Customers
growth-positive
Neurim Pharmaceuticals Receives Positive CHMP Opinion for Slenyto (Pediatric Prolonged-Release Melatonin) for the Treatment of Insomnia in Children With Autism Spectrum Disorder (ASD)
Neurim Pharmaceuticals has received a positive opinion from the CHMP for its pediatric prolonged-release melatonin coated tablets formulation, Slenyto, for the treatment of children and adolescents with ASD and/or Smith-Magenis Syndrome who suffer from insomnia. The recommendation is based on comprehensive data demonstrating the efficacy and safety of Slenyto in addressing the unmet need for ASD children with impaired sleep. If approved, Slenyto would be the only approved medicinal product for sleep disorders in pediatric ASD patients. Insomnia disproportionately affects children with ASD, and currently, there is no approved treatment for insomnia in this population.
Customers
growth-positive
Neurim Pharmaceuticals Grants Exeltis Marketing Rights for Paediatric Prolonged-Release Melatonin ("PedPRM") in Spain
Neurim Pharmaceuticals has entered into a license agreement with Exeltis, granting Exeltis exclusive marketing rights for Neurims new Rx PedPRM in Spain. PedPRM is a sleep medication designed to treat sleep disorders in children with Autism Spectrum Disorders and neurogenetic diseases. The collaboration with Exeltis will increase the accessibility of the drug to children and their families. Neurim Pharmaceuticals focuses on making PedPRM commercially available in all markets. Exeltis, a division of Chemo Group, specializes in insomnia and has a presence in Neurology. The agreement reinforces their partnership, which began with the licensing of Circadin in Spain.
Partners
growth-positive
Neurim Pharma reports success in Alzheimer's disease trial
Neurim Pharmaceuticals has completed an initial efficacy trial for its drug Circadin, which is currently used to treat sleep disorders, to determine its effectiveness in treating early-stage Alzheimers disease. The trial involved 80 patients with Alzheimers, with half receiving Circadin in addition to their regular treatment. The results showed that the group treated with Circadin had significantly fewer Alzheimers symptoms compared to the control group. Neurim Pharmaceuticals was founded by Prof. Nava Zisapel and is currently sold in 40 countries. The companys main investors are Nava and Yehuda Zisapel.
Customers
