Neurim said that the drug has already been approved by European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic) and the Israeli Ministry of Health (MOH).
Neurim Pharma said that the current approval is based on the primary data from Sounder-Sleep Phase IV clinical study.
The data from the study suggested that Circadin was safe and effective than placebo for at least 3 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.
Nava Zisapel, CSO of Neurim Pharmaceuticals, said: “We are pleased that the EMA recognised 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. Importantly, Circadin’s efficacy was maintained for at least 3 months and safety was maintained over the entire six months of treatment.”
Tali Nir, VP of clinical and regulatory affairs at Neurim Pharmaceuticals, said: “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.”