Slenyto
Psychiatry· 580 cited findings· 3 source documents
Company: RAD Neurim Pharmaceuticals
What the regulatory reviews say
Slenyto, approved in 2017, is indicated 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. A proposed expansion of its indication includes the 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. The CHMP has recommended acceptance of this indication extension.
In efficacy studies, Slenyto-treated groups showed an average sleep onset latency reduction of 39.6 minutes, compared to a 12.51 minutes reduction in placebo-treated groups. The average sleep duration increase in placebo-treated groups was 9.14 minutes. Baseline sleep-onset latency was 42.1+/-12.0 minutes. In a double-blind, placebo-controlled crossover study, melatonin decreased sleep-onset latency by 19.1+/-5.3 minutes.
Safety data includes 1.5% of Slenyto cases involving adults and 20 adverse events related to psychiatric disorders for Slenyto. No adverse effects were reported with melatonin. A total of 118 children were treated with Slenyto, with a mean time on treatment of 89.1 days during the double-blind phase.
Key figures — cited to the source page
| Average sleep onset latency reduction in Slenyto-treated group | 39.6 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.32 |
| Average sleep onset latency reduction in placebo-treated group | 12.51 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.32 |
| Average sleep duration increase in placebo-treated group | 9.14 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.32 |
| Slenyto cases involving adults | 1.5 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.25 |
| Number of AEs for Slenyto (psychiatric disorders) | 20 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.25 |
| Approval year for Slenyto | 2017 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.80 |
| New therapeutic indication age range | 6-17 | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.33 |
| CHMP recommendation for Slenyto indication extension | accepted | RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.82 |
Source documents
- RAD Neurim Pharmaceuticals — Slenyto EMA EPAR public assessment report (EMEA/H/C/004425, 2018) (2018)
- RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation assessment report (EMEA/H/C/004425, 2018) (2018)
- RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation assessment report (EMEA/H/C/004425, 2018) (2018)
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.