Neurim Pharmaceuticals confirmed that the European Commission (EC) has approved a change in treatment duration with Circadin (melatonin) from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.
"We are pleased that the EMA recognized the importance of this therapeutic profile and recommended approval of the change in the posology of Circadin from 3 weeks to 3 months of treatment," said Professor Nava Zisapel, CSO of Neurim Pharmaceuticals. "Importantly, Circadin’s efficacy was maintained for at least 3 months and safety was maintained over the entire 6 months of treatment."
The approval was based primarily on data obtained in the latest SOUNDER-SLEEP Phase IV clinical study, indicating that Circadin was safe and more effective than placebo for at least 3 months.
The latest study was a large randomized clinical trial that analyzed more than 600 patients, over 400 of whom were on Circadin treatment for 6 months. The study demonstrated improvements in sleep latency, quality of sleep, and morning alertness, with no withdrawal symptoms and rebound insomnia. The safety and efficacy data provided in the study support the proposed changes in treatment duration. In particular, the analysis of data from the new study showed that the benefit observed after 3 weeks is maintained for at least 3 months. Moreover, at 3 months, about an extra 10% of responders were seen in the Circadin-treated group.
Circadin is a sleep medication that has been approved by the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic), and the Israeli Ministry of Health (MOH) for the short-term treatment of primary insomnia, characterized by poor quality of sleep in patients who are aged 55 and over.
