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Positive Phase II Results for Insomnia Drug Piromelatine

Significant improvements in sleep parameters versus placebo (Feb. 18)

Positive results have been reported from a phase II clinical study of piromelatine (Neu-P11, Neurim Pharmaceuticals) — an investigational sleep medicine developed for the treatment of patients with primary and comorbid insomnia. The new results are from a recent double-blind, randomized, placebo-controlled, parallel-group study that evaluated piromelatine versus placebo in 120 adult primary insomnia patients.

Four weeks of treatment with piromelatine (20 or 50 mg) resulted in statistically significant and clinically meaningful improvements compared with placebo in key polysomnographic (PSG) parameters, including Wake After Sleep Onset (WASO) (P = 0.02 for both doses) and WASO for the first 6 hours of sleep (WASO-6h) (P = 0.0008 and P = 0.04 for the 50-mg and 20-mg doses, respectively). Piromelatine 50 mg also significantly improved Sleep Efficiency (SEF) (P = 0.02), Total Sleep Time (TST) (P = 0.02), Total Time Awake (TTA) (P = 0.01), and time in NREM sleep (P = 0.028) compared with placebo.

Subjective improvements in quality of sleep and total sleep time, measured by the Pittsburg Sleep Quality Questionnaire (PSQI), were also observed with piromelatine versus placebo, confirming the PSG findings.

Piromelatine was generally safe and well tolerated. The drug had no detrimental effects on next-day psychomotor performance — as assessed by the Digit Symbol Substitution Test (DSST) — for any dose group, and no deleterious effects on sleep structure and architecture.

According to the drug’s developer, piromelatine is believed to work through a combination of MT1/MT2 receptor(potential sleep-promoting and chronobiotic effects) and 5HT1A/D receptor (potential anxiolytic and analgesic effects) agonism.

Source: Neurim Pharmaceuticals; February 18, 2013.

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