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
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
Circadin (http://www.Circadin.com) is an
innovative sleep medication that has been approved by the European
Medicines Agency (EMA), the