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FDA Approves Takeda's Orzeyful for Narcolepsy Type 1 in Adults

· via neurologylive.com

FDA Approves Takeda's Orzeyful for Narcolepsy Type 1 in Adults

Neurologylive.com reports that the United States Food and Drug Administration has approved Takeda’s Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adults. The medication is an oral orexin receptor 2 (OX2R)-selective agonist and represents the first approved therapy for narcolepsy type 1 that directly targets the loss of orexin signaling while addressing the condition’s full range of symptoms.

The approval was supported by two randomized, double-blind, placebo-controlled 12-week Phase 3 clinical trials, FirstLight (NCT06470828) and RadiantLight (NCT06505031), which together enrolled 273 adult patients with narcolepsy type 1. Outlets report that Orzeyful is administered as an oral tablet twice daily, with a recommended trial dosage of 2 mg. The drug is contraindicated in patients taking strong CYP3A inhibitors. Additionally, it has been recommended for scheduling under the Controlled Substances Act, with a final scheduling decision from the Drug Enforcement Administration currently pending.

Common Questions

How is Orzeyful administered and taken?
Orzeyful is an oral tablet taken twice daily. In clinical trials, the recommended dose mentioned was 2 mg.
What evidence supported the FDA approval of Orzeyful?
The approval was based on two 12-week Phase 3 studies, FirstLight and RadiantLight. These randomized, double-blind, placebo-controlled trials enrolled a total of 273 adults with narcolepsy type 1.