Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months

07-Jul-2010 - Israel

Neurim Pharmaceuticals confirmed that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

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. Circadin is now the only sleep medication to be approved for up to 3 months.

The latest study was a large randomized clinical trial that analyzed more than 600 patients, over 400 of whom where 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.

"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, adding, "Importantly, Circadin's efficacy was maintained for at least 3 months and safety was maintained over the entire six months of treatment."

https://www.bionity.com/en/news/119747/circadin-is-approved-in-the-eu-for-treatment-of-primary-insomnia-in-patients-aged-55-or-over-for-up-to-3-months.html