Slenyto

Slenyto® has been designed to gradually release melatonin, mimicking the physiological secretion profile of melatonin that produces sustained plasma levels of melatonin for up to 8-10 hours.

Neurim received positive CHMP opinion for Slenyto® on July 26th 2018 (EMA/CHMP opinion). Slenyto® approval was based on a pediatric investigational plan (PIP) containing a Phase III study that demonstrated Slenyto®s’ short and long term efficacy and safety. This study showed significant improvements in total sleep time, sleep initiation and maintenance, child behaviour and caregivers’ quality of life 1 2 .

 

Slenyto® in the News

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  • Recent news

    • Slenyto® (PedPRM) was approved by EMA for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient
    • NEURIM PHARMACEUTICALS RECEIVES POSITIVE CHMP OPINION FOR SLENYTO® (PEDIATRIC PROLONGED-RELEASE MELATONIN) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH AUTISM SPECTRUM DISORDER (ASD)
    • Neurim Pharmaceuticals attends the INSAR Congress in Rotterdam, The Netherlands, May 9-11, 2018
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