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-- The application includes robust data from the Phase 3
registration program, which demonstrated efficacy of daridorexant on
objective and subjective sleep parameters, and an improvement in daytime
functioning, while maintaining a favorable safety profile
Allschwil, Switzerland -- March 10, 2021
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug
Administration (FDA) has accepted the new drug application (NDA) for
review of Idorsia's investigational dual orexin receptor antagonist,
daridorexant, for the treatment of adult patients with insomnia.
Insomnia is a common problem with approximately 25 million adults in the
US who meet the diagnostic criteria. Insomnia, a condition of overactive