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

July 5, 2010

TEL AVIV, Israel, July 5, 2010 /PRNewswire/ — Neurim Pharmaceuticals
(http://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 (http://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

About Circadin

Circadin (http://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.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals (http://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).

    For More information:
    Eran Schenker, MD
    Neurim Pharmaceuticals Ltd.
    Tel: +972-3-7684914 Cell: +972-52-6689944

SOURCE Neurim Pharmaceuticals LTD

Source: newswire

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