The FDA has approved Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults, marking the first therapy approved to treat the full range of symptoms associated with the disorder and the first to target its underlying biological cause.
Unlike existing treatments that address individual symptoms, Orzeyful restores orexin signaling by activating the same brain receptor as the naturally occurring chemical messenger lost in people with narcolepsy type 1, according to an Aug. 5 FDA news release. The oral medication is taken twice daily.
The approval was based on two randomized, double-blind, placebo-controlled 12-week studies involving 273 adults with narcolepsy type 1. Patients receiving the 2 milligram dose showed improvements in daytime wakefulness, daytime sleepiness and cataplexy, as well as sleep paralysis, hallucinations and disrupted nighttime sleep.
The FDA granted Orzeyful Breakthrough Therapy Designation and Priority Review. The drug was approved for Takeda Pharmaceuticals America and will be available after the Drug Enforcement Administration completes scheduling under the Controlled Substances Act.
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