Idorsia Receives the US FDA’s Breakthrough Therapy Designation for Daridorexant to Treat Pediatric Insomnia Disorder

Shots: The US FDA has granted Breakthrough Therapy Designation to Idorsia‘s daridorexant, a dual orexin receptor antagonist (DORA), for the treatment of insomnia disorder in pts aged 10 to <18yrs. The designation was supported by a P-II dose-finding study (n=165), which showed a significant dose-dependent improvement in total sleep time (p=0.0185); a single 50mg dose increased sleep time by 50 mins overall & 64 mins in pts with neurodevelopmental disorders Idorsia expects to initiate the pediatric P-III program in H2’27; no pharmacological treatment is currently approved by the FDA for pediatric insomnia disorder Ref: GlobeNewswire  |   Image: Idorsia  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Idorsia Receives the US FDA’s Breakthrough Therapy Designation for Daridorexant to Treat Pediatric Insomnia Disorder appeared first on PharmaShots.