Neurim reports positive Piromelatine Phase II study data

According to the double-blind, randomised study data, Piromelatine 20/50mg four-week treatment demonstrated statistically significant and clinically meaningful improvements in key polysomnographic (PSG) parametres such as Wake After Sleep Onset (WASO) and specifically WASO for the first six hours of sleep, compared to placebo..

Neurim CSO Prof. Nava Zisapel said, "Piromelatine demonstrates a good potential for the treatment of primary insomnia characterized by sleep maintenance disturbances as well as insomnia with psychiatric or medical co-morbidities."

Sleep efficiency, total sleep time, total time awake and time in NREM sleep were also improved by Piromelatine 50mg, indicating beneficial effects on sleep maintenance, in the non-confirmatory, sleep-laboratory study.

Subjective improvements against placebo in quality of sleep and total sleep time measured by the Pittsburg Sleep Quality Questionnaire.

Piromelatine, which was safe and well tolerated, improved NREM sleep EEG delta power and considerably reduced beta power.