First Digital Treatment for Generalized Anxiety Disorder Cleared by the FDA
The US Food and Drug Administration (FDA) has granted clearance to Big Health’s DaylightRx, a prescription digital therapeutic that delivers cognitive behavioral therapy to treat generalized anxiety disorder (GAD) in patients aged 22 and older. DaylightRx is the very first FDA-cleared digital treatment for GAD. This digital therapeutic can be ordered by a licensed health care provider and is meant to be an adjunct to usual care.
In randomized controlled trials, DaylightRx demonstrated efficacy in treating GAD with rates of remission of over 70% and significantly reduced anxiety in patients for up to 6 months or more.2 Specifically, in an online, 2-arm parallel-group superiority randomized controlled trial of 256 participants with moderate-to-severe symptoms of GAD, the digital therapeutic reduced symptoms of anxiety compared with waitlist control at postintervention, reflecting a large effect size (adjusted difference [95% CI]: 3.22 [2.14, 4.31], d = 1.08). Significant improvements were found in several domains: worry, depressive symptoms, sleep difficulty, well-being, and participant-specific quality of life. DaylightRx was delivered using the participants’ personal smartphones. Online assessments took place at baseline, mid-intervention (week 3; from randomization), postintervention (week 6; primary endpoint), and follow-up (week 10).
“For too long, patients seeking non-drug treatment options for anxiety have had limited choices. Now, with our FDA-cleared treatment, we are offering a powerful alternative with remission rates of over 70%. With this clearance, there is now an accessible non-medication option that patients can trust,” said Big Health CEO Yael Berman in a press release.
DaylightRx works by teaching patient users evidence-based techniques to alter the thoughts and behaviors that exacerbate chronic worry and anxiety via 90-day treatment. There are 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 also includes guided practice exercises to show patients how to integrate these techniques into their daily lives.
Big Health also had a product cleared by the FDA earlier year: SleepioRx for insomnia disorder. It is worth noting that the 2025 Medicare Physician Fee Schedule includes a proposal to pay for FDA-cleared digital mental health treatments, which would establish a pathway to scale access to DaylightRx, SleepioRx, and other digital therapeutics.
References
1. US FDA Grants Clearance for DaylightRx. Big Health. News release. September 4, 2024. Accessed September 5, 2024. https://www.bighealth.com/news/us-fda-grants-clearance-for-daylightrx
2. Carl JR, Miller CB, Henry AL, et al. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: a randomized controlled trial. Depress Anxiety. 2020;37(12):1168-1178.
