Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months

Tuesday, July 6, 2010 General News
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TEL AVIV, Israel, July 6, 2010 Neurim Pharmaceuticals( confirmed today that the European Commission (EC) hasapproved a change in treatment duration with Circadin from 3 to 13 weeks (3months). Circadin is indicated for the treatment of primary insomnia inpatients who are aged 55 or over.

The approval was based primarily on data obtained in the latestSOUNDER-SLEEP Phase IV clinical study, indicating that Circadin was safe andmore effective than placebo for at least 3 months. Circadin is now the onlysleep medication to be approved for up to 3 months.

The latest study was a large randomized clinical trial that analyzed morethan 600 patients, over 400 of whom where on Circadin treatment for 6 months.The study demonstrated improvements in sleep latency, quality of sleep andmorning alertness, with no withdrawal symptoms and rebound insomnia. Thesafety and efficacy data provided in the study support the proposed changesin treatment duration. In particular, the analysis of data from the new studyshowed that the benefit observed after 3 weeks is maintained for at least 3months. Moreover, at 3 months, about an extra 10% of responders were seen inthe Circadin treated group.

Circadin ( is an innovative sleep medication thathas been approved by the European Medicines Agency (EMA), the AustralianTherapeutic Goods Administration (TGA), the Swiss Agency for TherapeuticProducts (SwissMedic) and the Israeli Ministry of Health (MOH) for theshort-term treatment of primary insomnia, characterized by poor quality ofsleep in patients who are aged 55 and over. The approval is based on clinicalstudies demonstrating positive effects on sleep quality, sleep induction, andmost importantly next day alertness and functioning.

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

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

About Circadin

Circadin ( is the first and only IP-protectedprolonged-release melatonin to be approved as an ethical drug by healthauthorities. Administration of Circadin to patients with primary insomniaimproves sleep quality and morning alertness and facilitates sleep onset inpatients aged 55 or over. Now it is also the first insomnia treatmentapproved for up to 13 weeks. Currently Circadin is commercialized in Europeby H.Lundbeck A/S and Nycomed, in Australia by Sigma, in Thailand by DKSH andin Israel by Teva. Circadin is undergoing registration in US, Asia and LatinAmerican markets.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals ( is headquartered in Israelwith offices in Switzerland and the UK. The company was founded in 1991 andis focused on drug discovery and development of treatments for age-relateddisorders, primarily in the central nervous system (CNS).For More information: Eran Schenker, MD Neurim Pharmaceuticals Ltd. Tel: +972-3-7684914 Cell: +972-52-6689944

SOURCE Neurim Pharmaceuticals LTD

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