Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months
TEL AVIV, Israel, July 5, 2010 /PRNewswire/ -- Neurim Pharmaceuticals (http://www.Neurim.com) confirmed today 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.
Circadin (http://www.Circadin.com) is an innovative sleep medication that has been approved by the European Medicines Agency (EMA), the