FDA Clears First Drug For Blindness Sleep Disorder
WASHINGTON (AP) -- U.S. health regulators on Friday approved the first drug to treat a sleep disorder that mainly afflicts the blind.
The Food and Drug Administration cleared Vanda Pharmaceuticals' Hetlioz capsules for patients who have problems sleeping because they can't detect light. The condition, called non-24-hour disorder, is estimated to affect up to 100,000 Americans, most of whom are totally blind. These people can find their sleep patterns reversed — sleeping during the day and being awake at night.
Vanda said in a statement it would launch the drug in the second quarter.
The most common side effects of the drug include headache, nightmares and respiratory and urinary tract infections. The drug labeling warns that Hetlioz causes drowsiness and can interfere with performing basic tasks and mental alertness.
Analysts estimate the drug could reap sales of more than $350 million annually.
The FDA said it approved the drug based on studies of 104 blind patients with non-24-disorder. The trials showed that patients who took the drug had more normalized sleeping patterns than patients taking placebo.
Washington DC-based Vanda Pharmaceuticals Inc. markets one other drug for schizophrenia.
Company shares rose 17 cents to close at $13.23.