Shots:
- The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy
- Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized 105 pts to 2 arms (2mg & PBO)
- Both trials demonstrated improvements across the full spectrum of disease symptoms, incl. excessive daytime sleepiness, cataplexy, and health-related quality of life
Ref: Businesswire | Image: Takeda | Press Release
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