Vanda Therapy Helps the Blind Sleep

 FDA Staff Says

Vanda Pharmaceuticals Inc.’s experimental drug should be approved to regulate the circadian rhythms of blind people and help them sleep, a U.S. regulatory reviewer said.

The medicine, known as tasimelteon, is effective at synchronizing the body with a 24-hour cycle, Food and Drug Administration staff said today in a report ahead of a Nov. 14 meeting of agency advisers.

 No approved treatments exist for the condition called non-24-hour disorder, which affects as many as 95,000 totally blind people in the U.S, Vanda said. Most people have a master body clock that naturally runs longer than 24 hours and light resets the clock, according to the Rockville, Maryland-based company.

Patients with non-24-hour disorder now try the hormone melatonin with mixed results. Vanda studied its compound’s ability to “entrain” or modify circadian rhythms.


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