London, 26 April 2007
Doc. Ref. EMEA/CHMP/114954/2007
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION*
International Nonproprietary Name (INN): melatonin
On 26 April 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Circadin, 2 mg, prolonged-release tablet intended for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over. The applicant for this medicinal product is Neurim Pharmaceuticals EEC Ltd.
The active substance of Circadin is melatonin, a hypnotic sleep regulating medicinal product, (ATC code: N05 CM17). Endogenous melatonin is a physiological neuro-hormone secreted by the pineal gland and involved in the circadian (light/dark) cycle. The mode of action of Circadin (exogenous melatonin) involves specific melatonin receptors in the brain (hypothalamus) but the hypnotic and sedative mechanism of Circadin remains unclear.
The benefits with Circadin are its improvement of the quality of sleep and the morning alertness based mainly on 2 pivotal clinical trials in patients aged more than 55 years and suffering from primary insomnia. The most common adverse events were pharyngitis, back pain and asthenia. There is no main safety concern.
A pharmacovigilance plan for Circadin, as for all medicinal products, will be implemented as part of the marketing authorisation.
The approved indication is: “Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over”
Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for Circadin and therefore recommends the granting of the marketing authorisation.
* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 67 days from adoption of the Opinion.
** Applicants may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.