Somryst is said to be the first prescription digital therapeutic for the treatment of chronic insomnia in the patients aged 22 years and older
The US FDA’s Center for Devices and Radiological Health (Credit: The U.S. Food and Drug Administration)
Pear Therapeutics has secured approval from the US Food and Drug Administration (FDA) for its prescription digital therapeutic (PDT), Somryst, to treat adults with chronic insomnia.
Somryst is claimed to be the first FDA-authorised PDT for the treatment of chronic insomnia in the patients aged 22 years and older.
Somryst is designed to offer neurobehavioral interventions
To improve the symptoms of insomnia, Somryst has been designed to provide neurobehavioral interventions, particularly cognitive behavioral therapy for insomnia (CBTi) and sleep restriction driven by algorithms.
The 9-week prescription digital therapeutic is comprised of features, which enable personalisation including the patient’s potential to set a sleep window.
The American Academy of Sleep Medicine and the American College of Physicians clinical guidelines suggest CBTi as a first-line treatment for people with chronic insomnia.
According to the company, Somryst is the only FDA-authorized therapeutic, which delivers guideline-recommended first-line treatment for chronic insomnia.
The approval was based on two randomized controlled trials, which assessed the efficacy of prescription digital therapeutic.
The 303-patient study showed meaningful improvements in insomnia severity, sleep onset latency and wake after sleep onset at the end of treatment, as well as at six and 12 months follow-up compared to active control, said the company.
Pear’s second study, which included 1,149 adult patients with chronic insomnia and depressive symptoms, has demonstrated a significant reduction in insomnia severity measurements compared to controls in the patients treated for nine weeks.
Pear Therapeutics president and CEO Dr Corey McCann said: “The FDA’s authorization of our third PDT, Somryst, demonstrates our ongoing commitment to redefine disease treatment through the development of PDTs.
“Now, more than ever, easily-accessible treatment options are imperative for patients suffering from chronic conditions. Pear has built the capabilities, pipeline, and platform to allow us to build PDTs that help patients across a variety of disease areas.”
In December 2019, Novartis division Sandoz and Pear Therapeutics have secured FDA approval for the reSET-O mobile medical application to treat opioid use disorder (OUD).