A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities
Latest Information Update: 26 Apr 2024
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At a glance
- Drugs Melatonin (Primary)
- Indications Insomnia; Sleep disorders
- Focus Registrational; Therapeutic Use
- Sponsors NEURIM Pharmaceuticals
- 05 Nov 2018 According to a Neurim Pharmaceuticals media release, SLENYTO(PEDPRM) WAS APPROVED BY EMA FOR THE TREATMENT OF INSOMNIA IN CHILDREN AND ADOLESCENTS AGED 2-18 WITH AUTISM SPECTRUM DISORDER (ASD) AND / OR SMITH-MAGENIS SYNDROME, WHERE SLEEP HYGIENE MEASURES HAVE BEEN INSUFFICIENT
- 30 Jul 2018 Results presented in a Neurim Pharmaceuticals media release.
- 30 Jul 2018 According to a Neurim Pharmaceuticals media release, 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.