Circadin Approved in EU for Treatment of Primary Insomnia

Neurim Pharmaceuticals (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 3 months.

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 group.

Circadin (www.Circadin.com) is an innovative sleep medication that has been approved by the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic) and the Israeli Ministry of Health (MOH) 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 demonstrating positive effects on sleep quality, sleep induction, and most importantly next day alertness and functioning.

"We are pleased that the EMA recognized the importance of this therapeutic profile and recommended approval of the change in the posology of Circadin from 3 weeks to 3 months of treatment," said Professor Nava Zisapel, CSO of Neurim Pharmaceuticals, adding, "Importantly, Circadin's efficacy was maintained for at least 3 months and safety was maintained over the entire six months of treatment."

Dr. Tali Nir, VP Clinical and Regulatory Affairs of Neurim Pharmaceuticals explained that in the case of some hypnotics, concerns of safety and potential dependence issues have led to restrictions in the permitted treatment duration to ultra short periods for 2 to 4 weeks. Adding, "With Circadin there are no safety concerns and no concerns regarding withdrawal or rebound effects, as demonstrated in the study, which would limit the recommendation to treat for the full 3 month short term treatment period."

Circadin (www.Circadin.com) 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. Now it is also the first insomnia treatment approved for up to 13 weeks. Currently Circadin is commercialized in Europe by H.Lundbeck A/S and Nycomed, in Australia by Sigma, in Thailand by DKSH and in Israel by Teva. Circadin is undergoing registration in US, Asia and Latin American markets.

Neurim Pharmaceuticals (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).