Patients who read about the first narcolepsy drug designed to treat the disease rather than its symptoms cannot get a prescription filled yet. Orzeyful, approved by the Food and Drug Administration on Aug. 5 for adults with narcolepsy type 1, has been recommended for scheduling under the Controlled Substances Act and will be lawful to market only after the Drug Enforcement Administration issues its scheduling decision.
That gap creates a practical problem for people living with narcolepsy type 1 and for the families who help manage the condition. The approval is real, the coverage has been widespread, and the medicine is not on a shelf anywhere. Takeda, the manufacturer, says it is advancing launch preparations and expects to make the drug available once the DEA process concludes. The Narcolepsy Network has told patients that the scheduling review is expected to be completed within 90 days and that distribution through a specialty pharmacy could begin as early as November.
