Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months
By Neurim Pharmaceuticals Ltd, PRNESunday, July 4, 2010
TEL AVIV, Israel, July 5, 2010 - 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."
About Circadin
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.
About Neurim Pharmaceuticals
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).
For More information: Eran Schenker, MD Neurim Pharmaceuticals Ltd. Tel: +972-3-7684914 Cell: +972-52-6689944 EranS@Neurim.com
For More information: Eran Schenker, MD, Neurim Pharmaceuticals Ltd., Tel: +972-3-7684914, Cell: +972-52-6689944, EranS at Neurim.com
Tags: Israel, July 5, Neurim Pharmaceuticals LTD, Tel aviv