Neurim Pharmaceuticals has reported positive data from a Phase II study of Piromelatine (Neu-P11), for the treatment of primary and co-morbid insomnia.
The double-blind, randomised study assessed piromelatine in comparison with placebo in 120 adult primary insomnia patients.
Neurim CSO Professor Nava Zisapel said; "Piromelatine demonstrates a good potential for the treatment of primary insomnia characterised by sleep maintenance disturbances as well as insomnia with psychiatric or medical co-morbidities."
In the placebo-controlled, parallel group study, Piromelatine 20/50mg treatment for four weeks demonstrated statistically significant and clinically meaningful improvements in key polysomnographic (PSG) parameters such as wake after sleep onset (WASO) and specifically WASO for the first six hours of sleep, compared to placebo.
Piromelatine 50mg also improved sleep efficiency, total sleep time, total time awake and time in NREM sleep, representing beneficial effects on sleep maintenance, in the non-confirmatory, sleep-laboratory study.
The PSG findings were confirmed by observing subjective improvements against placebo in quality of sleep, and total sleep time measured by the Pittsburg Sleep Quality Questionnaire (PSQI).
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Piromelatine, which improved NREM sleep EEG delta power and considerably reduced beta power, was safe and well-tolerated.
No harmful effects related to Piromelatine were noted on next-day psychomotor performance for any dose group, and no damaging effects on sleep structure and architecture were observed.