The US Food and Drug Administration (FDA) has granted authorization for Somryst, the first prescription digital therapeutic (PDT) intended for use in the treatment of patients 22 years of age and older with chronic insomnia. Marketed by Pear Therapeutics Inc, Somryst is the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0.
Somryst is intended to provide tailored neurobehavioral interventions, specifically cognitive behavioral therapy for insomnia (CBTi) and sleep restriction driven by algorithms designed to improve the symptoms of insomnia. Somryst includes features that allow for personalization including the patient’s ability to set a sleep window. The American Academy of Sleep Medicine and the American College of Physicians clinical guidelines recommend CBTi as first-line treatment for people with chronic insomnia. Somryst is the only FDA-authorized therapeutic that delivers guideline recommended first-line treatment for chronic insomnia.
“More than 30 million adults suffer from chronic insomnia, which can seriously impact one’s quality of life and can lead to depression, suicidality, hypertension, and even heart attacks. Treatment options for chronic insomnia are limited as most available sleep medications are only recommended for short term use, can lead to problems with tolerance, and can have unwanted side-effects, including next-day cognitive impairments,” says Charles M. Morin, PhD, professor of psychology, Director Sleep Research Centre at Université Laval in Quebec City, in a release. “The authorization of Somryst by the FDA provides patients suffering from chronic insomnia with a digitally-delivered CBTi therapeutic, where CBTi is the guideline recommended long-term, first-line treatment for chronic insomnia.”
The FDA submission was supported by two randomized controlled trials evaluating the effectiveness of the therapeutic. Together, these studies enrolled more than 1,400 adults with chronic insomnia. In a trial of 303 patients with chronic insomnia, those on treatment demonstrated clinically meaningful improvements in insomnia severity, sleep onset latency (time to fall asleep) and wake after sleep onset (time awake at night) at the end of treatment, as well as at 6 and 12 months follow-up compared to active control. Results of the study were published in JAMA Psychiatry. In a second study of 1,149 adult patients with chronic insomnia and depressive symptoms, those on treatment for 9 weeks saw a significant reduction in insomnia severity measurements compared to controls. These benefits persisted for over a 12-month period. The majority of patients randomized to the treatment arm for the PDT candidate no longer met clinical criteria for insomnia at the end of the 9-week treatment. Results of the study were published in Lancet Psychiatry.
“The FDA’s authorization of our third PDT, Somryst, demonstrates our ongoing commitment to redefine disease treatment through the development of PDTs,” says Corey McCann, MD, PhD, president and CEO of Pear Therapeutics, in a release. “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.”
Somryst was submitted, reviewed, and cleared through the traditional 510(k) pathway and was the first product reviewed through FDA’s Software Precertification Pilot Program, as part of the 2019 Test Plan released by the FDA in January 2019. Pear Therapeutics is one of nine companies taking part in the FDA’s Digital Health Software Precertification Pilot Program. As part of the program, Pear has been working closely with the FDA and volunteered to undergo the first-ever Excellence Appraisal in May 2019, consisting of an onsite evaluation of the company’s commitment and execution across product quality, patient safety, cybersecurity responsibility, clinical responsibility, and a proactive culture.