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 summarizes the assessment of a Type II variation for Slenyto (melatonin), extending its indication to treat insomnia in children and adolescents aged 6-17 with ADHD, where sleep hygiene is insufficient. The original authorization was for insomnia in children with ASD/neurogenetic disorders. The new indication is supported by a subgroup analysis of the phase III study NEU_CH_7911, demonstrating improved total sleep time and sleep onset latency. The age range was narrowed from 2-18 to 6-17 due to insufficient data for younger children. Slenyto was generally safe, with common adverse events including somnolence and fatigue. The benefit-risk balance is positive, leading to approval of the variation, and a safety concern regarding delayed sexual maturation was removed from the Risk Management Plan.
Key findings — cited to the page
| Study NEU_CH_7911 Slenyto arm N | 60 | NEU_CH_7911 · p.9 |
| Average sleep duration increase in placebo-treated group | 9.14 minutes | · p.32 |
| Number of AEs for Slenyto (psychiatric disorders) | 20 | · p.25 |
| Slenyto cases involving adults | 1.5 % | · p.25 |
| New therapeutic indication age range | 6-17 years | · p.33 |
| Procedure Number | EMEA/H/C/004425/II/0028 | Slenyto · p.1 |
| Marketing Authorization Grant Date | 20 September 2018 | Slenyto · EU · p.6 |
| Average sleep onset latency reduction in Slenyto-treated group | 39.6 minutes | · p.32 |
| Average sleep onset latency reduction in placebo-treated group | 12.51 minutes | · p.32 |
| Study NEU_CH_7911 randomization N | 125 | NEU_CH_7911 · p.8 |
| Study NEU_CH_7911 mean age | 8.7 years | NEU_CH_7911 · p.8 |
| Study NEU_CH_7911 placebo arm N | 65 | NEU_CH_7911 · p.9 |
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 →