Neurim Pharmaceuticals Announces Positive Top-Line Results from Pivotal Phase III Trial of Paediatric Prolonged-Release Melatonin (PedPRM) for Sleep Disturbances in Children with Autism Spectrum Disorders (ASD)
TEL AVIV, Israel, November 2, 2016 /PRNewswire/ --
Neurim Pharmaceuticals ("Neurim") announced today top-line results from its NEU_CH_7911 Phase III study. PedPRM met the primary efficacy endpoint demonstrating statistically significant improvement in total sleep time (TST) compared to placebo. In addition to TST, secondary efficacy endpoints demonstrating improvements in sleep initiation and maintenance were also met. Safety profile was similar between PedPRM and placebo-treated groups.
This was a randomized, double-blind, placebo-controlled, parallel group, multi-center (EU and USA) study in children with ASD or neurogenetic diseases and sleep disorders. Patients (125), who had not shown improvement practicing sleep hygiene, received 2 weeks placebo run-in, and then randomized to PedPRM (2mg with optional increase to 5mg) or placebo in the evening, for 13 weeks. Completers received PedPRM open-label for additional 13 weeks. Primary efficacy endpoint was defined as the difference between PedPRM and placebo in mean change from run-in to the end of double-blind treatment period, in parent-reported TST (Daily Sleep and Nap Diary). Results from this study will be presented at upcoming medical congresses.
"PedPRM significantly improved sleep initiation and maintenance, while maintaining a favourable safety profile" said Dr. Tali Nir, DVM, VP Regulatory and Clinical Affairs of Neurim Pharmaceuticals. "Importantly, beyond the benefit to children's sleep, we have observed gradual improvements in parents' daytime alertness and children's social functioning."
"There are no approved sleep medications for the paediatric population" said Prof. Nava Zisapel, PhD, Chief Scientific Officer of Neurim Pharmaceuticals. "We are proud to bring a potentially new effective and safe treatment to children with ASD living with severe sleep disturbances and their families."
PedPRM is an age-appropriate formulation designed for populations with swallowing difficulties. It was developed in response to the unmet medical need in the field of paediatric insomnia under EU-PIP (http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500212192.pdf) and US-FDA IND. Patients currently continue in a 78-week, open-label follow-up study, assessing long-term efficacy and safety of PedPRM. Neurim is moving forward with regulatory submissions for this product.
ABOUT NEURIM PHARMACEUTICALS
Neurim Pharmaceuticals Ltd. (http://www.neurim.com ) is a neuroscience drug discovery and development company. Its first approved drug CircadinŪ is commercially available in more than 45 countries around the world.
Neurim has a strong and innovative product pipeline, intended for insomnia, Alzheimer's disease, dementia, glaucoma and pain.
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