About 200,000 people in the U.S. and 3 million worldwide have the condition, and the symptoms can range from feeling tired during the day to suddenly and unexpectedly falling asleep and losing muscle control. There’s no cure for narcolepsy, and doctors generally treat it with stimulant drugs or amphetamines as well as behavior changes like scheduled naps to control the sleepiness episodes.
Because patients feel better on Orzeyful, the drug is now being reviewed by the Drug Enforcement Administration (DEA) for any addictive potential, and Takeda CEO and president Julie Kim tells TIME she expects it to receive a schedule IV designation, which indicates a low chance of dependence or abuse.
That decision might have been easier because the company was already testing another compound in parallel—Orzeyful—which turned out to be safer. “It’s in how the molecule is designed,” says Kim, about how Orzeyful can target the same pathway but be more potent and have fewer side effects.
Kim’s confidence lies in the fact that Ozeyful targets a specific orexin receptor, and researchers know that there is at least one other receptor that could be a strong candidate for another drug. Already, Takeda scientists are studying another orexin-based drug for narcolepsy type 2 and idiopathic hypersomnia, or excessive sleepiness even after a full night’s sleep. “These people already have orexin circulating in the body, but they might need more of it,” says Kim. “So this is a different molecule that we can dose higher than Orzeyful and hopefully we will see positive data.”
It’s part of Takeda’s strategy to build a portfolio of drugs that could treat a range of sleep disorders, says Kim. “You can imagine if we can broaden out to [other disorders], whether it’s obstructive sleep apnea, or insomnia or ever things like jet lag—there is tremendous potential here. We are going to follow the science and look at designing molecules to fit different purposes.”
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