FDA OKs Digital Therapeutic for Generalized Anxiety Disorder
The United States Food and Drug Administration (FDA) has granted clearance for DaylightRx, a prescription digital therapeutic designed to treat generalized anxiety disorder (GAD). The prescription device, created by Big Health, is indicated as an adjunctive treatment to standard care in patients 22 and older.
DaylightRx expands upon Big Health’s existing mobile app, Daylight, which launched in 2019 to assist users in reducing their feelings of worry and anxiety. A 2020 randomized control trial involving 256 participants with moderate-to-severe GAD recorded significant improvement in depressive symptoms, sleep difficulty, wellbeing, and quality of life in those using Daylight (adjusted difference [95% CI]: 3.22 [2.14, 4.31], d = 1.08).
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DaylightRx itself is a 90-day program that delivers cognitive behavioral therapy (CBT) to its users, seeking to reduce GAD symptoms though a variety of strategies including relaxation exercises to ease tension, stimulus control to reduce frequency of worry, cognitive restructuring to disrupt anxious thoughts, and exposure therapy to reduce worry intensity.
"For too long, patients seeking non-drug treatment options for anxiety have had limited choices,” said Big Health CEO Yael Berman. “Now, with our FDA-cleared treatment, we're offering a powerful alternative with remission rates of over 70 percent.”
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