Pharmaceutical Business review

Vanda initiates phase II excessive sleepiness trial

The trial will investigate the efficacy and safety of three oral doses of VSF-173 for the treatment of induced excessive sleepiness in approximately 60 healthy male and female subjects. The primary endpoint of the study is the difference from placebo on the maintenance of wakefulness test (MWT), a standard measure of sleepiness.

Excessive sleepiness is a common symptom that can significantly impair a person's ability to function. The effects of ecessive sleepiness range from mild sleepiness to unrecognized episodes of “microsleeps” and uncontrollable sleep attacks. Excessive sleepiness is a symptom of many disorders including, obstructive sleep apnea, narcolepsy, shift worker sleep disorder, Parkinson's, and Alzheimer's disease.