Neurim has declared the preliminary results of phase-III study of Circadin 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients.
Circadinis, a sleep medicine, has been approved by the European Commission Pharmaceutical Regulatory Agency and the Israeli Ministry of Health for the short-term treatment of primary insomnia in patients aged 55 and over.
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.
Nava Zisapel, CSO of Neurim, said: We are very excited about these preliminary Phase III results, because Circadin has demonstrated long term efficacy and safety.