Shots:

• The approval was based on the P-III clinical program i.e., Study 1&2 evaluate Quviviq (20/50mg) vs PBO in 1854 patients with insomnia at ~160 sites across 18 countries. The therapy is expected to be available in May 2022
• The results showed an improvement on objective measures of sleep onset, sleep maintenance & patient-reported total sleep time while 50mg dose in one of the 2 studies showed a reduction in patient-reported daytime sleepiness as measured by sleepiness domain score from IDSIQ @ 1& 3mos.
• The results for the 25mg dose did not reach statistical significance. Quviviq is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexins

 Ref: Idorsia | Image: Idorsia