Nov 12 An experimental sleep disorder drug made
by Vanda Pharmaceuticals Inc is safe and effective
enough to warrant approval, a U.S. Food and Drug Administration
The report, posted on the FDA's website on Tuesday, comes
two days ahead of a meeting of outside medical experts who will
discuss the drug and recommend whether or not it should be
approved. The FDA is not bound to follow the advice of its
advisory panels but typically does so.
The drug, tasimelteon, is designed to treat Non-24-Hour
Disorder, or Non-24, a circadian rhythm disorder that is most
commonly found in the totally blind and can cause disrupted
nighttime sleep patterns and excessive daytime sleepiness.