RAD Neurim Pharmaceuticals — Slenyto EMA EPAR public assessment report (EMEA/H/C/004425, 2018)
RAD Neurim Pharmaceuticals · 2018 · EMA EPAR public assessment report
Report summary
The EMA EPAR for Slenyto (melatonin) details its regulatory assessment for treating insomnia in children (2-18) with Autism Spectrum Disorders and neurogenetic diseases. The application, submitted by RAD Neurim Pharmaceuticals, received a positive opinion in July 2018. The report covers pharmaceutical development, quality control, and non-clinical safety, including genotoxicity, carcinogenicity, and reproductive toxicity, concluding melatonin lacks tumorigenic potential. Clinical pharmacology and efficacy data from a randomized, placebo-controlled trial (NEU_CH_7911) demonstrated significant improvements in total sleep time and sleep latency, with sustained benefits over 52 weeks. Slenyto also improved caregiver sleep quality and well-being. Safety data from adult and pediatric populations showed common adverse events like somnolence, headache, and fatigue, with no significant impact on laboratory parameters or hormonal axes. A risk management plan addresses potential pubertal development effects. The CHMP concluded a positive benefit-risk balance, recommending marketing authorization for this specific indication.
Key findings — cited to the page
| caregiver PSQI score change from baseline | 1.79 units | · p.53 |
| Circadin sleep onset delay | 44.0% | Circadin · p.53 |
| caregiver PSQI score change from baseline | -2.20 units | · p.53 |
| caregiver CSDI satisfaction of child's sleep patterns | 1.95 | · p.53 |
| caregiver CSDI satisfaction of child's sleep patterns | 1.9 units | · p.53 |
| Application submission date | 3 January 2017 | Slenyto · p.9 |
| EMA/CHMP eligibility agreement date | 1 April 2016 | Slenyto · p.9 |
| Marketing authorisation positive opinion date | 26 July 2018 | Slenyto · p.10 |
| Age range for PIP waiver | 0-2 years | · p.12 |
| caregiver WHO-5 score change from baseline | 2.41 units | · p.53 |
| caregiver WHO-5 score change from baseline | 1.96 units | · p.53 |
| Circadin sleep duration increase | 10.1% | Circadin · p.53 |
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 →