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. Some Practical Ideas On Rational Plans Of Eye Bags | Guidance For That ViewNava 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.” ABOUT PedPRM 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.
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