Takeda starts US sales of narcolepsy drug Orzeyful after DEA ruling

what happened

Takeda has started selling its narcolepsy tablet Orzeyful in the United States, the company said. The launch followed a decision by the Drug Enforcement Administration that cleared the final regulatory obstacle. The agency placed the drug in Schedule IV, a class seen as carrying low potential for abuse and dependence. According to Reuters, Schedule II carries tighter controls, while Schedule V is the least restrictive.

The Food and Drug Administration approved the pill in August for narcolepsy type 1, a rare condition tied to the loss of brain cells that make orexin. Unlike treatments that only ease symptoms, Orzeyful targets the breakdown in orexin signaling. It is taken twice a day. Takeda estimates that about 120,000 people in the US have the disorder. Prescriptions will be filled through Cigna's Accredo specialty unit. Rhonda Pacheco, president of Takeda's US business, said early efforts will focus on adults who still have breakthrough symptoms despite other medicines, adding that half of people with the disease remain undiagnosed.

why it matters

For Takeda, this is a new product in a narrow rare-disease niche. In trials, the drug helped patients stay awake during the day better than placebo and significantly reduced cataplexy episodes. The US list price is $16,500 per 60-tablet bottle across all strengths. Investors will watch early prescription volumes.

market impact

Takeda: a new drug in a rare-disease niche adds to revenue, with limited effect on the wider market

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