US FDA Grants Clearance for DaylightRx

SAN FRANCISCO, Sept. 4, 2024 /PRNewswire/ -- Big Health, a leading developer of digital mental health treatments, has been granted clearance by the U.S. Food and Drug Administration (FDA) for its digital therapeutic, DaylightRx. DaylightRx is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. DaylightRx is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.

DaylightRx is the first FDA-cleared digital treatment for generalized anxiety disorder. DaylightRx is an innovative digital formulation of cognitive behavioral therapy for GAD that teaches patients evidence-based techniques to change the thoughts and behaviors that maintain chronic worry and anxiety. DaylightRx includes interactive lessons on applied relaxation to reduce tension, stimulus control to decrease worry frequency, cognitive restructuring to break the spiral of anxious thoughts, and exposure to reduce intensity of worry. DaylightRx includes guided practice exercises designed to support patients in integrating these techniques into their daily lives. DaylightRx is a 90-day treatment.

GAD is a chronic and debilitating condition in which patients experience excessive, uncontrollable worry that is associated with physical symptoms and significant interference in day-to-day functioning. Generalized anxiety disorder has also been associated with increased risk for a number of other conditions, including depression1, diabetes,2 heart disease,3 and hypertension.4 Anxiety disorders, including GAD, are some of the most common and costly mental health conditions with a cost to U.S. economy of over $53B per year.5

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