Takeda launches sleep disorder pill in the US after DEA clearance removes final hurdle
TAK•Takeda said its narcolepsy pill Orzeyful is now available by prescription in the US after the DEA classified it as a Schedule IV controlled substance. The FDA approved the drug in August for narcolepsy type 1, which affects about 120,000 people in the US, according to the company.
1. US rollout begins
Takeda said Orzeyful, a twice-daily pill for narcolepsy type 1, is now available in the US after the DEA classified it as a Schedule IV controlled substance, removing the final regulatory hurdle for its rollout. It will be dispensed by prescription through Cigna’s Accredo Specialty Pharmacy.
2. Targets underlying cause
The FDA approved the treatment in August. Unlike treatments that address symptoms, Orzeyful targets the loss of orexin signaling that causes the disorder. In studies, it improved patients’ ability to stay awake during the day compared with placebo and significantly reduced episodes of cataplexy.
3. Initial launch focus
Takeda said it will initially focus on adults cycling through other treatments or taking multiple medications while still experiencing breakthrough symptoms. Company executive Rhonda Pacheco said about 50% of people with the rare disease are not diagnosed.
