| "Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced the initiation of a Phase II clinical trial of its product candidate VSF-173 in excessive sleepiness (ES)." " The trial is a randomized, double-blind, placebo-controlled study to 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 (ES) is a common symptom that can significantly impair a person's ability to function. The effects of ES 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." " ES may have significant consequences ranging from impairment in social and occupational functioning to severe accidents. According to the National Sleep Foundation 2005 Sleep in America Poll, 43% of adults reported that they are so sleepy during the day that it interferes with their daily activities a few days per month or more and 22% experience this level of daytime sleepiness at least a few days per week. According to the same poll, 60% of adult drivers say they have driven a vehicle while feeling drowsy in the past year, and more than one-third of adult drivers have actually fallen asleep at the wheel. ES make lapses of attention more likely to occur, and may play a role in behavior that can lead to automobile accidents." " This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Vanda's plans for its product candidates. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vanda is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, a failure of ... read the whole article |