for the treatment of adult patients with insomnia
• 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 wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on a
Idorsia Pharmaceuticals Ltd: FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia
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 wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.
FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
• 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
The Edge: Serotonin Syndrome, Neuroleptic Malignant Syndrome, and Malignant Hyperthermia emsworld.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from emsworld.com Daily Mail and Mail on Sunday newspapers.