Tel Aviv, July 24, 2011
Neurim Pharmaceuticals Ltd. is pleased to provide its latest trial results evaluating the effects of its insomnia drug Circadin® (prolonged-release melatonin) compared to Zolpidem and placebo on postural stability (body sway) in healthy middle aged volunteers.
Postural instability, also referred to as body sway, increases with age and is considered to be an important risk factor for falls and fracture among hypnotic drugs users.
The study objective was to evaluate the effect of Circadin® on postural stability in older adults awaken in the middle of the night. Twenty four healthy volunteers (age 55-64) completed a single-dose, 3-way crossover study of postural stability (body sway) after bedtime administration of Circadin® 2 mg (melatonin), zolpidem 10 mg or placebo with 7-10 days of washout between treatments.
Subjects were tested for postural stability 15 minutes before drug administration (at bedtime) and after 1.5 and 4 hours. Subjects were asked to stand on a stabliometric platform with their eyes closed and open. Parameters tested were the area of the 95% confidence ellipse enclosing the Center of Pressure (COP [A95]) and length of the COP path. Adverse events were recorded throughout the study.
No significant differences were found between Circadin® and placebo in body sway as measured by the A95 parameter and by the length of the COP, except minor differences at 4 hours under open eyes conditions. Zolpidem, on the other hand, significantly increased body sway as measured by the A95. The results indicate that Circadin® does not impair postural stability during mid sleep awakening, while the positive control zolpidem validated the study by significantly increasing postural instability under these conditions.
“This data confirms that Circadin® does not raise the risk of falls, which is a major concern with hypnotic drugs use.” said Dr. Tali Nir, VP Clinical and Regulatory Affairs of Neurim Pharmaceuticals, “Our study confirms prior evidence that zolpidem has a negative effect on postural stability, that is causally related to the increase in risk of falls and injuries in patients aged 55+ years.”
Circadin® 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. It is currently commercialized in Europe & Asia-Pacific territories.
About Neurim Pharmaceuticals
Neurim Pharmaceuticals is headquartered in Israel with offices in Switzerland and the UK. The company was founded in 1991 and is focused on the central nervous system (CNS), primarily in age-related disorders.