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GNW: FDA accepts the new drug application for review of Idorsia's daridorexant | Newsticker

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 maintai ....

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Idorsia Pharmaceuticals Ltd: FDA accepts the new drug application for review of Idorsia's daridorexant for the treatment of adult patients with insomnia

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. ....

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FDA accepts the new drug application for review of Idorsia's daridorexant for the treatment of ...

FDA accepts the new drug application for review of Idorsia's daridorexant for the treatment of ...
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Idorsia Pharmaceuticals Ltd: Idorsia submits European marketing authorisation application for daridorexant 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 ....

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The Edge: Serotonin Syndrome, Neuroleptic Malignant Syndrome, and Malignant Hyperthermia

The Edge: Serotonin Syndrome, Neuroleptic Malignant Syndrome, and Malignant Hyperthermia
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