RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation assessment report (EMEA/H/C/004425, 2018)
RAD Neurim Pharmaceuticals · 2018 · EMA EPAR variation assessment report
Report summary
This report details a Type II variation application for Slenyto (prolonged-release melatonin) to expand its indication for insomnia treatment in children and adolescents (2-18 years) with neurodevelopmental disorders, specifically Angelman, Rett, Tuberous Sclerosis Complex, and Williams syndromes, when sleep hygiene is insufficient. These conditions are often linked to impaired melatonin secretion and significant sleep disturbances. The application is supported by a Phase III study (NEU_CH_7911) demonstrating Slenyto's efficacy in improving total sleep time and sleep latency in children with ASD or SMS, post-marketing data, and literature reviews. A French Real-World Use study with Circadin (melatonin) also showed improved sleep quality in a large cohort. The report highlights that whole, prolonged-release tablets are more effective. While data for these specific neurogenetic disorders is limited, the general efficacy and safety profile of Slenyto/Circadin are considered applicable, with no new safety concerns identified. The CHMP recommended extending the indication based on these findings.
Key findings — cited to the page
| Sleep efficiency at baseline | 68.0+/-3.9 % | · p.14 |
| Awakenings per night at baseline | 15+/-2 | · p.14 |
| Study design | randomized, double-blind, placebo-controlled crossover study | · p.14 |
| Number of participants | 9 | · p.14 |
| Sleep-onset latency at baseline | 42.1+/-12.0 minutes | · p.14 |
| Total sleep time at baseline | 7.5+/-0.3 hours | · p.14 |
| Current Slenyto indication | 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 | Slenyto · p.6 |
| Proposed Slenyto indication expansion | treatment of insomnia in children and adolescents aged 2-18 years with neurodevelopmental disorders associated with neurogenetic disorders (Angelman syndrome, Rett syndrome, Tuberous sclerosis complex and Williams syndrome), where sleep hygiene measures have been insufficient | Slenyto · p.6 |
| Approval year for Slenyto | 2017 | Slenyto · p.80 |
| Adverse effects with melatonin | No adverse effects | · p.14 |
| Initial marketing authorization date | 20 September 2018 | Slenyto · European Union · p.6 |
| Sleep-onset latency decrease with melatonin | 19.1+/-5.3 minutes | · p.14 |
Source: RAD Neurim Pharmaceuticals ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →