FDA

DaylightRx receives FDA approval for generalized anxiety disorder treatment

September 11, 2024

Big Health, a leading developer of digital mental health treatments, received FDA clearance for its prescription digital therapeutic, DaylightRx. The device delivers cognitive behavioral therapy (CBT) and is designed to treat symptoms of generalized anxiety disorder (GAD) as an adjunct to usual care in patients 22 years and older.

According to the manufacturer’s news release, DaylightRx is a digital formulation of CBT for GAD that teaches patients evidence-based techniques to change the thoughts and behaviors that lead to chronic worry and anxiety. The 90-day treatment 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. Guided practice exercises are designed to support patients in integrating these techniques into their daily lives.

FDA clearance was based on data from multiple clinical trials, including a randomized controlled trial that evaluated the effectiveness of DaylightRx compared with psychoeducation in improving anxiety in GAD. Findings showed treatment with digital CBT significantly improved anxiety symptoms in adults with GAD.

Source:

(2024, September 4). Big Health. US FDA grants clearance for DaylightRx. [News release]. https://www.bighealth.com/news/us-fda-grants-clearance-for-daylightrx