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Neurim Pharmaceuticals Receives Positive CHMP Opinion for Slenyto (Pediatric Prolonged-Release Melatonin) for the Treatment of Insomnia in Children With Autism Spectrum Disorder (ASD)

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Neurim Pharmaceuticals Receives Positive CHMP Opinion for Slenyto (Pediatric Prolonged-Release Melatonin) for the Treatment of Insomnia in Children With Autism Spectrum Disorder (ASD)

- Slenyto® is the first recommended child-appropriate insomnia treatment for children with ASD

- Recommendation is based on a pediatric investigational plan (PIP) that includes a Phase III study which demonstrated Slenyto®s' (PedPRM) efficacy and safety

- Phase III study showed significant improvements in total sleep time (TST), sleep initiation and maintenance, child behaviour and caregivers' quality of life1

PR Newswire

TEL AVIV, Israel, July 30, 2018 /PRNewswire/ -- Neurim Pharmaceuticals ("Neurim") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Slenyto®, a pediatric prolonged-release melatonin coated tablets formulation for the treatment of children and adolescents with ASD and/or Smith-Magenis Syndrome who suffer from insomnia. The CHMP recommendation is based on results of Slenyto® comprehensive data package demonstrating short and long-term (2 years) efficacy and safety of this child-appropriate, easy-to-swallow drug for insomnia in ASD children.

"The positive CHMP opinion of our PedPRM formulation represents a significant milestone in addressing an unmet need for ASD children who suffer severely from impaired sleep. If approved, Slenyto® would be the only medicinal product approved for sleep disorders in pediatric ASD patients being both efficacious and safe in the short- and long-term and is dose-adjustable, at a dose of 2mg, 5mg or 10mg according to individual response," said Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals.

Commenting on the announcement, Paul Gringras, Professor of Children's Sleep Medicine and Neurodisability Evelina London Children's Hospital, England and Principal Investigator of the Phase III study said: "This exciting international robust study found that paediatric prolonged release melatonin was both an effective and safe medication for insomnia refractory to sleep behavioural intervention in children with autistic spectrum disorders. Adjusting the dosage according to individual response was easy and the formulation was exceptionally well tolerated in this population. The results demonstrated clinically significant improvements in sleep duration, latency and maintenance. Related measures of children's daytime mood and behaviours also improve with this treatment, as does the parental quality of life. The treatment will address a significant need in the medical management of some children and adolescents with autistic spectrum disorders."

ABOUT INSOMNIA IN AUTISM SPECTRUM DISORDER (ASD) CHILDREN

Approximately 1,000,000 children in Europe are diagnosed as being on the Autistic Spectrum. Insomnia disproportionately affects children with ASD (50-86%) compared to typically developing children (1-6%)2. The severity of sleep problems is of particular concern in light of the increased burden and stress experienced in parenting a child with an ASD and the potentially adverse effects of sleep disturbances and insufficient sleep on daytime behaviour and functioning. 

Currently there is no approved treatment for insomnia in ASD children and current practices recommend parent-directed behavioral sleep interventions as first-line treatment for pediatric insomnia in ASD, with reportedly a 25% response rate.

ABOUT SLENYTO® (PEDPRM)

Slenyto® is an age-appropriate formulation of prolonged-release melatonin, a hormone involved in regulation of the circadian clock and sleep. The mini-tablet innovative formulation was designed to facilitate swallowing for the ASD pediatric population, in response to the unmet medical need in the field of insomnia. PedPRM was developed under EU-PIP and US-FDA IND.

Slenyto® Phase III Study Results

The pivotal phase III study was a randomized, double-blind, placebo-controlled, parallel group, multi-center (EU and USA) study in children with ASD or neurogenetic diseases and sleep disorders. 125 patients, who had not shown improvement after standard sleep behavioural intervention, received 2 weeks placebo run-in, were randomized to 13 weeks Slenyto®/placebo treatment followed by 91 weeks open-label follow up phase, and 2 weeks single-blind placebo period, altogether 2.2 years. Primary efficacy endpoint demonstrated that ASD children slept on average 57.5 minutes longer at night with Slenyto® compared to 9.14 with placebo (p=0.034), Sleep Latency decreased by 39.6 minutes on average with Slenyto® and 12.5 with placebo (p=0.011) without causing earlier wakeup time. Additional results showed that Slenyto® alleviated insomnia-related difficulties in externalizing behavior (e.g. hyperactivity/inattention and conduct) and improved caregivers Quality of Life.

ABOUT NEURIM PHARMACEUTICALS

Neurim Pharmaceuticals Ltd. (www.neurim.com) 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 including Europe, Asia-Pacific, Latin America, Africa and the Middle East.

Neurim has a strong and innovative product pipeline targeting diseases such as insomnia, Alzheimer's disease, dementia, and pain.

References:
1. Gringras, P., Nir, T., Breddy, J., Frydman-Marom, A. & Findling, R.L. (2017) J American Academy of Child & Adolescent. Psychiatry, 56, 948-957.e944.
2. Mindell, J.A., Emslie, G., Blumer, J., Genel, M., Glaze, D., Ivanenko, A., Johnson, K., Rosen, C., Steinberg, F., Roth, T. & Banas, B. (2006). Pediatrics, 117, e1223-1232.

Contact: Adi Zisapel
Chief Commercial Officer
+972-3-7684905/+972-54-5967616
adiz@neurim.com

 

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SOURCE Neurim Pharmaceuticals Ltd.

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