FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder
DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.
The FDA has granted clearance to the digital therapeutic DaylightRX for the treatment of generalized anxiety disorder (GAD) as an adjunct to usual care in patients aged 22 years and older, Big Health announced in a release.1 The therapy is the first digital treatment approved to treat GAD in the United States.
FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder / Tada Images - stock.adobe.com
DaylightRX is a digital formulation of cognitive behavioral therapy (CBT) and includes lessons that teach patients different evidence-based techniques to help reduce chronic worry and anxiety, including applied relaxation, stimulus control, cognitive restructuring, and exposure therapy. The therapy, which is available by prescription only, was developed based on Big Health’s existing digital care program Daylight.
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“I am thrilled to announce that we have secured a landmark clearance of DaylightRx for the treatment of generalized anxiety disorder,” Yael Berman, CEO of Big health, said in a post on LinkedIn.2 “This is the first FDA cleared digital treatment for generalized anxiety disorder, paving the way for these accessible, effective treatments to support millions of patients worldwide.”
The clearance of DaylightRX was based on data from randomized controlled trials, including a randomized, partially blind, parallel-group, superiority phase 2 trial that evaluated the efficacy of Daylight compared with a waitlist control in individuals who had moderate to severe GAD symptoms. Findings from the study were published in the journal Depression and Anxiety.3
The study cohort included 256 adult patients who randomly received either Daylight or were part of a control group. Patients in the treatment group received digital CBT therapy via an app on their own smartphone. The primary endpoint was GAD symptoms as measured by the GAD-7-item post-intervention. Key secondary endpoints included effects on worry, depressive symptoms, sleep difficulty, wellbeing, and participant-specific quality of life.
Investigators conducted online assessments at baseline (week 0), mid-intervention (week 3), post-intervention (week 6), and follow-up (week 10). Patients in the intervention arm were also invited to complete a longer-term uncontrolled assessment at Week 26.
The study found that patients who received Daylight had significantly reduced anxiety symptoms at week 6 compared to the control group. At week 10, 71% of patients in the treatment group achieved remission of GAD, compared to 33% in the control group. The improvements in symptoms were seen to be sustained at week 26. The therapy also significantly improved measures of worry, depressive symptoms, sleep difficulty, wellbeing, and participant-specific quality of life.4
Daylight was safe and effective, with only 1 participant reporting an adverse event related to difficulty accessing the intervention. Patients in the treatment group reported significantly fewer occurrences of unwanted symptoms, including low mood, fatigue and/or exhaustion, extreme sleepiness, feeling agitated, difficulty remembering things, headache and/or migraine, difficulty concentrating and focusing on things, and reduced motivation and/or energy.
"For too long, patients seeking non-drug treatment options for anxiety have had limited choices,” Berman said in a release.1 “Now, with our FDA-cleared treatment, we're offering a powerful alternative with remission rates of over 70 percent. With this clearance, there is now an accessible non-medication option that patients can trust.”
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References
1. US FDA Grants Clearance for DaylightRx. News Release. Big Health. September 4, 2024. Accessed September 4, 2024. https://www.bighealth.com/news/us-fda-grants-clearance-for-daylightrx
2. Yael Berman LinkedIn page. I am thrilled to announce that we have secured a landmark clearance of DaylightRx for the treatment of generalized anxiety disorder. This is the first FDA cleared digital treatment for generalized anxiety disorder, paving the way for these accessible, effective treatments to support millions of patients worldwide. What is equally exciting is that this is the second FDA clearance for Big Health in the past month—most recently, for SleepioRx to treat insomnia.
For too long, patients seeking non-drug treatment options for anxiety have had limited choices. Now, with our FDA-cleared treatment, we're offering a powerful alternative with remission rates of over 70 percent. With this clearance, there is now an accessible non-medication option that patients and providers can trust.
I want to credit our CMO, Jenna Carl, PhD, for leading the Big Health team down the FDA path, from establishing our strategy several years ago to achieving two successful FDA clearances. Additional acknowledgment to our world-class research and regulatory team, particularly Tali Ball, PhD (DaylightRx) and Alasdair Henry, PhD (SleepioRx), who led and managed all aspects of the clinical trials and submissions, and Reuben Lawson for his deep regulatory expertise and guidance. And a big thank you to the many others who guided and supported this multi-year effort, including Dani Bradley, Christopher B. Miller PhD, Colin A. Espie, Peter Hames, Arun Gupta, and Anand Shah, MD. Accessed September 4, 2024. https://www.linkedin.com/feed/update/urn:li:activity:7237106266165116928/
3. Carl JR, Miller CB, Henry AL, Davis ML, Stott R, Smits JAJ, Emsley R, Gu J, Shin O, Otto MW, Craske MG, Saunders KEA, Goodwin GM, Espie CA. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depress Anxiety. 2020 Dec;37(12):1168-1178. doi: 10.1002/da.23079. Epub 2020 Jul 29. PMID: 32725848.
4. Landmark Randomized Controlled Trial Demonstrates Efficacy of Daylight™ Digital Therapeutic in Improving Anxiety. News Release. Big Health. July 29, 2020. Accessed September 4, 2024. https://www.bighealth.com/news/randomized-controlled-trial-demonstrates-efficacy-of-daylight-for-improving-anxiety
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