Tel Aviv, June 21, 2016
Neurim Pharmaceuticals announced today that l’Agence Nationale de Sécurité du Médicament (ANSM), the French National Agency for Medicines and Health Products Safety, issued a Temporary Recommendation for the Use (RTU) of Circadin®, prolonged-release melatonin 2mg, and is reimbursing the costs of treatment for children aged 6 to 18 suffering from sleep-wake rhythm disorders associated with Autism Spectrum Disorders (ASD) and neurogenetic diseases.
Temporary Recommendation for Use (RTU) was granted in September 2015 by ANSM1 after evaluating Circadin® benefit/risk ratio for these patients. This is to allow Circadin® use for an unmet therapeutic need, and to ensure the appropriate monitoring of the treated children in order to gather more safety and efficacy information on its use in this population. Neurim Pharmaceuticals and its partner Biocodex, which markets Circadin® in France, have undertaken the responsibility to follow up on the treated patient according to the commitment under the RTU.
The French authorities have now granted a reimbursement for Circadin® treatment to this population2. “The reimbursement for Circadin® treatment for this vulnerable population is yet another positive regulatory nod on the efficacy and safety of Circadin® in this age group.” said Adi Zisapel, CCO at Neurim Pharmaceuticals, “We are pleased to be granted with the RTU that will allow this much-needed therapy for the children and their families”.
Dr. Tali Nir, VP Clinical and Regulatory Affairs at Neurim Pharmaceuticals added that the company is developing a new age-appropriate oral solid dosage form of prolonged-release melatonin for this population: “We are excited to be in the very last stage of completing a Phase III clinical trial for the regulatory approval of our age-appropriate mini-tablets in children with ASD and neurogenetic diseases who suffer from sleep disturbances”.
Circadin® is the only approved melatonin based sleep medication and is currently approved by regulatory agencies around the world for the treatment of primary insomnia in patients aged 55 and over. Approval was based on positive effects of Circadin® on sleep quality, sleep induction, and daytime functioning without impairing cognitive performance.
An age appropriate form of prolonged-release melatonin is currently studied in a Phase III study, under a Paediatric Investigational Plan (PIP) agreed with the European Medicines Agency (EMA)3.
About Neurim Pharmaceuticals
Neurim Pharmaceuticals Ltd., founded in 1991 is a drug discovery and development company focused on the central nervous system (CNS). Its first approved drug, Circadin® – prolonged-release melatonin for insomnia is commercially available in more than 40 countries around the world.