SEATTLE, - Neurim Pharmaceuticals 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) 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(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."
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