Takeda launches sleep disorder pill in the US after DEA clearance removes final hurdle
TAK•Takeda said Orzeyful, its narcolepsy type 1 treatment, is now available by prescription in the US after DEA clearance. The list price is $16,500 per 60-tablet bottle across all strengths.
1. US launch begins
Takeda said its twice-daily narcolepsy pill Orzeyful is now available in the US after the Drug Enforcement Administration classified it as a Schedule IV controlled substance. It will be dispensed through Cigna's Accredo Specialty Pharmacy.
2. Price and treatment
The US list price is $16,500 per 60-tablet bottle across all strengths. Analysts said the price was below expectations, although in line with current standard-of-care therapies. The FDA approved Orzeyful in August for narcolepsy type 1; the drug targets loss of orexin signaling, the underlying cause of the disorder.
3. Launch focus
Takeda said it will initially focus on adults who continue to experience symptoms while using other treatments or multiple medications. The company estimates about 120,000 people in the US have the disorder, and said 50% of people with the disease are undiagnosed.
