Neurim announced positive top-line results from its NEU_CH_7911 Phase 3 study evaluating the efficacy and safety of PedPRM (pediatric prolonged-release melatonin), an age-appropriate formulation for pediatric insomnia, designed for those with swallowing difficulties. There are currently no approved sleep medications for the pediatric population.

The randomized, double-blind, placebo-controlled trial included 125 child participants with ASD or neurogenetic diseases and sleep disorders. Each patient 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. 

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PedPRM met its primary endpoint of demonstrating statistically significant improvement, from the 2 week run-in baseline, in parent-reported total sleep time (TST) compared to placebo. The safety profile was similar for the PedPRM and placebo treated groups. 

“PedPRM significantly improved sleep initiation and maintenance, while maintaining a favorable safety profile,” said Dr. Tali Nir, DVM, VP Regulatory and Clinical Affairs of Neurim Pharmaceuticals. 

The long-term efficacy is currently being assessed in the same patients, for a 78-week open-label follow-up study. The full results form the study will be presented at upcoming medical congresses. 

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