Pear Therapeutics is seeking an approval from the US Food and Drug Administration (FDA) for its prescription digital therapeutic (PDT), Somryst.
The company has filed a marketing application to the FDA for Somryst to treat adults with chronic insomnia and depression.
Somryst is claimed to be the first product submitted to the FDA via Software Pre-certification Pilot Programme under the 2019 Test Plan released by the FDA in January this year.
Somryst is designed to offer neurobehavioral interventions, particularly cognitive behavioural therapy for insomnia (CBTi) and sleep restriction driven by learning algorithms to decrease the severity of insomnia and symptoms of depression.
CBTi is considered as first-line treatment for chronic insomnia, but it currently has no FDA-authorised therapeutics.
Pear Therapeutics has submitted the application based on data from two randomised controlled trials assessing the effectiveness of the investigational PDT.
Both trials recruited over 1,400 adults with chronic insomnia, of which around 1,100 are already suffering with depression.
The treatment arm secured the investigational PDT and the comparator arm received an attention-matched digital placebo along with usual care in the study conducted over the course of nine weeks with more than 1,100 adults with chronic insomnia and depression.
Results have been measured at baseline, at nine weeks, and post-treatment at six months, 12 months, and 18 months.
According to the company, the adults randomised to the investigational PDT showed a reduction in mean Insomnia Severity Index (ISI) score to 7.27 from a baseline of mean 15.92, while the control patients showed a reduction in ISI score to a mean of 13.17 from a baseline of mean 16.23 at the end of a 9-week treatment course.
Pear Therapeutics president and CEO Dr Corey McCann said: “Prescription digital therapeutics are a new treatment class that use software applications to directly treat serious disease. PDTs are designed to deliver evidence-based treatment anytime, anywhere, while also providing clinicians with real-time data on patient progress.
“Pear Therapeutics is the leader in this emerging space. If authorized, Somryst could become our third FDA-authorized PDT, representing a new wave of innovation for patients and physicians.”