Piromelatine, a new multi-modal sleep medicine developed for the treatment of primary and co-morbid insomnia, yielded positive results from a phase II clinical study that will be presented at the upcoming Associated Professional Sleep Societies/Sleep meeting.
The study evaluated Piromelatine compared to placebo in 120 adult primary insomnia patients, ages 18 years and older.
Results showed that Piromelatine 20/50 mg treatment for 4 weeks resulted in “statistically significant and clinically meaningful improvements” in key PSG parameters, including Wake After Sleep Onset, particularly for the first 6 hours of sleep.
Piromelatine 50 mg also improved sleep efficiency, total sleep time, total time awake, and time in NREM sleep, according to Neurim.
The drug was generally safe and well tolerated, had no detrimental effects on next-day psychomotor performance for any dose group, and had no deleterious effects on sleep structure and architecture, according to the company.
“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,” said Professor Nava Zisapel, chief science officer of Neurim.