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On January 10, 2022, Idorsia announced that the U.
This approval is based on positive results from a Phase 3 clinical program
The primary efficacy endpoints of both trials were the change in time required to enter sustained sleep (LPS) and wake after sleep onset (WASO) from baseline to months 1 and 3
▲ Orexin stimulates multiple signaling pathways that promote wakefulness (Image source: Reference [2])
Results of the Phase 3 clinical program showed that Quviviq at a dose of 50 mg significantly improved objective measures of sleep onset and sleep maintenance, as well as patient-reported total sleep time, compared with placebo
(Original abridged)