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.
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.
For more information Neurim.com.