TEL-AVIV, Israel, July 30,
2024 /PRNewswire/ -- Neurim Pharmaceuticals
("Neurim") announces that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has adopted
a positive opinion, recommending an extension to the existing
indication to include the treatment of Insomnia in children with
Neurogenetic disorders (NGDs).
Slenyto® is a child appropriate prolonged release melatonin
formulation that was approved in the EU in 2018 for the treatment
of insomnia in children with autism spectrum disorder (ASD) and/ or
Smith-Magenis Syndrome. Slenyto® is the only authorised
medication for insomnia in these disorders.
The adopted recommended wording for the extended indication is:
"Slenyto® is indicated for the treatment of insomnia in children
and adolescents aged 2-18 with autism spectrum disorder (ASD)
and/or neurogenetic disorders with aberrant diurnal melatonin
secretion and /or nocturnal awakenings, where sleep hygiene
measures have been insufficient".
"The positive CHMP opinion on Slenyto® represents a
significant milestone in addressing an unmet need for children
with NGDs, who suffer severely from impaired sleep. Upon
approval, Slenyto® would be the only medicinal product
approved for sleep disorders in this unique paediatric population,
allowing treatment initiation at an early age," said Prof. Nava
Zisapel, CEO of Neurim Pharmaceuticals.
Paul Gringras, Professor of
paediatric Sleep Medicine, London,
England commented: "Melatonin deficiency or misalignment
is a common pathophysiological mechanism for insomnia in
neurogenetic disorders. Slenyto® is a prolonged-release
formulation of melatonin that delivers melatonin over the course of
the night, mimicking the endogenous release profile in healthy
subjects. Therefore, Slenyto® has the potential to treat the
pathophysiology of insomnia in this population improving sleep
latency, sleep continuity and total nighttime sleep duration.
Slenyto® has been specifically formulated for use in
children and has a favorable safety profile. The treatment will
address a significant need in the medical management of many
children and adolescents with NGDs".
ABOUT INSOMNIA IN CHILDREN WITH NEUROGENETIC DISORDERS
(NGDs)
Sleep impairment is a common comorbidity in neurogenetic
disorders, with up to 86% of children reported to experience
disrupted sleep, starting at an early age. During early childhood,
sleep plays an essential role in healthy cognitive and psychosocial
brain development, influencing learning memory, emotional
regulation, and brain structure. Children with neurogenetic
disorders tend to develop insomnia and other sleep disorders at an
early age. Insomnia has a significant impact on these children,
aggravating disease symptoms and reducing quality of life in both
patients and caregivers.
Current practices recommend parent-directed behavioral sleep
interventions as first-line treatment for pediatric insomnia in
NGDs, with a 25% response rate. Slenyto® will be the first approved
pharmacological treatment for insomnia in children and adolescents
with NGDs.
ABOUT SLENYTO®
Slenyto® is an age-appropriate prolonged-release
formulation of melatonin, a hormone involved in the regulation of
circadian clock and sleep. The mini-tablet innovative formulation
was specifically designed to facilitate ease of swallowing without
resistance in pediatric ASD and NGD population, in response to the
unmet medical need in the field of paediatric insomnia.
Slenyto® delivers melatonin over the night to mimic the
endogenous melatonin release profile in healthy subjects. In a
Phase III study in ASD and SMS children and adolescents, Slenyto®
improved sleep latency, sleep continuity and total nighttime sleep
duration. The positive effect on sleep maintenance and duration was
associated with an improvement in externalizing behavior, which
correlated with an improvement in parents' well-being.
The mechanism of action of Slenyto® on sleep latency,
sleep maintenance and total sleep time is independent of the
background disorder. Therefore, any patient with a neurogenetic
disorder with sleep disturbances associated with aberrant diurnal
melatonin secretion patterns and/or insufficient nighttime
melatonin secretion will benefit from Slenyto®.
ABOUT NEURIM PHARMACEUTICALS
Neurim Pharmaceuticals Ltd. (www.neurim.com) is a neuroscience
drug discovery and development company. Its first approved drug,
CIRCADIN®, is approved for patients over the age of 55 who are
suffering from insomnia and is commercially available in 45
countries around the world, including Europe, Asia-Pacific, Latin
America, Africa and the
Middle East.
Neurim has a strong and innovative product pipeline targeting
central nervous system (CNS) disorders.
Contact:
Guy
Manor
VP Commercial
Operations
guym@neurim.com
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