FDA approves Takeda's Orzeyful, a novel orexin-based pill for type 1 narcolepsy

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The Food and Drug Administration on Wednesday approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions.

The twice-a-day pill, which will be marketed as Orzeyful, is an orexin receptor agonist. It’s cleared to treat narcolepsy type 1, a taxing condition in which patients have a deficiency of the orexin neuron and experience bouts of sleepiness and muscle weakness during the day.

The drug will likely be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse and patients still feel sleepy while taking them. In two Phase 3 trials , Orzeyful helped patients stay awake during the day for much longer than what’s been seen with current treatments. Throughout the studies, participants also reported less daytime sleepiness, less frequent muscle weakness, and greater attentiveness.

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