SEATTLE, June 11 /CNW/ - Neurim Pharmaceuticals (http://www.neurim.com)
presented today the preliminary results of a large-scale Phase III study of
Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long
term efficacy and safety in elderly patients. The results were reported in the
Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the
Associated Professional Sleep Societies, (APSS) held at Seattle, Washington.
The SLEEP meeting attracts the largest audience of sleep specialists in world.
Circadin(R) (http://www.Circadin.info) is a novel sleep medicine that has
been approved by the European Commission pharmaceutical regulatory agency and
the Israeli Ministry of Health for the short-term treatment of primary
insomnia, characterized by poor quality of sleep in patients who are aged 55
and over. The approval is based on clinical studies showing positive effects
on sleep quality, sleep induction, and most importantly next day alertness and
The new double blind placebo controlled trial with more than 790 insomnia
patients aged 18-80, shows that 6 months continuous treatment with Circadin(R)
is both safe and efficacious. The trial demonstrated improvements in sleep
latency, quality of sleep and morning alertness particularly in elderly
patients, with no withdrawal symptoms and rebound insomnia. "We are very
excited about these preliminary Phase III results" said Professor Nava
Zisapel, CSO of Neurim Pharmaceuticals, "because Circadin(R), previously shown
to be a unique short term treatment for poor sleep quality, has now
demonstrated long term efficacy and safety."
Circadin(R) (http://www.Circadin.info) is the first and only IP-protected
prolonged-release melatonin to be approved as an ethical drug by health
authorities. Administration of Circadin(R) to patients with primary insomnia
improves sleep quality and morning alertness and facilitates sleep onset in
patients aged 55 or over. Currently commercialized in Europe by H.Lundbeck A/S
and Nycomed, and in Israel by Teva, Circadin(R) is undergoing registration in
US, Asia-Pacific and Latin American markets.
About Neurim Pharmaceuticals
Neurim Pharmaceuticals (http://www.neurim.com) is headquartered in Israel
with offices in Switzerland and the UK. The company was founded in 1991 and is
focused on drug discovery and development of treatments for age-related
disorders, primarily in the central nervous system (CNS).
For further information:
For further information: Eran Schenker, MD, Medical Director & Corporate
Business Development, Neurim Pharmaceuticals Ltd., Tel: +972-3-7684914, Cell: