The U.S. Food and Drug Administration headquarters is shown in Silver Spring, Md. File photo by Jim Lo Scalzo/EPA-EFE/
Aug. 5 (UPI) — The U.S. Food and Drug Administration has approved the first drug to treat a “full range” of narcolepsy type 1 symptoms in adults, the FDA said Wednesday.
A release by the agency said the drug, Orzeyful (oveporexton), addresses the range of symptoms that define the disease, a rare, lifelong neuropsychiatric sleep disorder. It is the first to work by directly targeting the loss of orexin signaling that causes the disorder.
“For too long, people with narcolepsy type 1 have had to manage a complex, lifelong neuropsychiatric with treatments that only address pieces of it,” said Tiffany Farchione, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research. “This new drug is the first medicine that impacts the underlying biology of the disease, treating narcolepsytype 1 as a whole.”
Narcolepsy type 1 is caused by the loss of brain cells that produce orexin, a chemical messenger that controls wakefulness, sleep and muscle tone, the FDA said in its release. This cause symptoms including excessive daytime sleepiness, cataplexy (sudden muscle weakness cause by strong emotions), sleep paralysis, disrupted nighttime sleep and hallucinations at the edge of sleep or waking.
The medicine is taken as an oral tablet twice daily. The FDA said Orzeyful directly activates the same brain receptor that naturallyproduced orexin would stimulate.
The approval of Orzeyful for this purpose was granted to Takeda Pharmaceuticals America, the FDA said.
