Big Health, a US-based provider of digital treatments for mental health, has received the US Food and Drug Administration (FDA) approval for its digital therapeutic product, DaylightRx.
DaylightRx is an advanced digital formulation of cognitive behavioural therapy indicated for the treatment of generalised anxiety disorder (GAD) in patients aged 22 years and above.
It is offered as a prescription device and by order of a licensed healthcare provider.
The digital therapy, as an adjunct to usual care, teaches evidence-based techniques to help patients change their thoughts and behaviours that trigger chronic worry and anxiety.
The 90-day treatment includes interactive lessons on applied relaxation to reduce tension, stimulus control to decrease worry frequency, and cognitive restructuring.
It works to break the vortex of anxious thoughts, and exposure to reduce the intensity of worry.
Also, DaylightRx comprises guided practice exercises that support patients in integrating relaxation techniques into their daily lives.
The company said DaylightRx, developed based on its existing Daylight digital care programme, is the first FDA-approved digital treatment for generalised anxiety disorder.
Big Health CEO Yael Berman said: “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%. With this clearance, there is now an accessible non-medication option that patients can trust.”
Big Health said its DaylightRx delivers cognitive behavioural therapy by improving the patient’s GAD symptoms.
In randomised controlled trials, the device showed efficacy in treating GAD, with remission rates exceeding 70%, and significantly reduced anxiety for up to 6 months or more.
The company said DaylightRx is its second product to receive FDA approval this year, following SleepioRx, its digital therapeutic approved for the treatment of insomnia, last month.
