Tel aviv, June 11, 2009
Neurim Pharmaceuticals presented today the preliminary results of a large-scale Phase III study of Circadin® 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® 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 functioning.
The new double blind placebo controlled trial with more than 790 insomnia patients aged 18-80, shows that 6 months continuous treatment with Circadin® 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®, previously shown to be a unique short term treatment for poor sleep quality, has now demonstrated long term efficacy and safety.”
Circadin® is the first and only IP-protected prolonged-release melatonin to be approved as an ethical drug by health authorities. Administration of Circadin® 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® is undergoing registration in US, Asia-Pacific and Latin American markets.
About Neurim Pharmaceuticals
Neurim Pharmaceuticals 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).