Boston-based Pear Therapeutics filed a submission to the US Food and Drug Administration (FDA) seeking marketing authorization for Somryst, a prescription digital therapeutic intended for use in the treatment of adults with chronic insomnia and depression. Depression is the most common co-occurring disorder with insomnia.

Somryst is intended to provide tailored neurobehavioral interventions, specifically cognitive behavioral therapy for insomnia (CBT-I) and sleep restriction driven by learning algorithms to reduce the severity of insomnia and symptoms of depression. CBT-I is considered firstline treatment for chronic insomnia, but most people do not have access to nor receive the recommended treatment, and there currently are no FDA-authorized therapeutics that deliver CBTi.

“One in three adults suffer from symptoms of insomnia in a given week and more than 30 million adults have chronic insomnia. Chronic insomnia can have an impact on quality of life—and can put people at risk long-term for depression, hypertension, and even heart attack,” says Charles M. Morin, PhD, professor of psychology and director  of the Sleep Research Centre at Université Laval in Quebec City, Canada, in a release. “Most adults with insomnia receive medication intended for short-term use or struggle with insomnia without receiving effective, lasting treatment. Somryst could facilitate patient access to CBTi treatment with appropriate clinical oversight and management from clinicians.”

The FDA submission is supported by two randomized controlled trials evaluating the effectiveness of the investigational prescription digital therapeutic. Together, these studies enrolled more than 1,400 adults with chronic insomnia, approximately 1,100 of whom also had depression. In the largest study, conducted over the course of nine weeks with more than 1,100 adults with chronic insomnia and depression, the treatment arm received the investigational prescription digital therapeutic, and the comparator arm received an attention-matched digital placebo along with usual care. Results were measured at baseline, at nine weeks, and post-treatment at six months, 12 months, and 18 months. At the end of a 9-week treatment course adults randomized to the investigational prescription digital therapeutic showed a reduction in mean Insomnia Severity Index (ISI) score to 7.27, from baseline of mean 15.92, while the control patients of showed a reduction in ISI score to a mean of 13.17, from a baseline of mean 16.23 (LS Mean Differences of -5.90, (95% CI, -6.68, -5.11); p < 0.0001). The treatment group also showed a reduction in depression severity, as measured by the Patient Health Questionnaire 9 (PHQ9), to a mean score of 3.78, from a baseline mean of 8.03, while control patients showed reduction to a mean PHQ9 score of 6.20, from a mean of 7.84 at baseline (LS Mean Differences -2.42, (95% CI, -3.01, -1.83); p < 0.0001).

The majority of patients randomized to the investigational prescription digital therapeutic treatment arm no longer met criteria for insomnia or depression at the end of the 9-week treatment. Clinical improvements persisted to 18 months following the initial 9-week treatment course. In addition, the study showed improvements in anxiety symptoms (as measured by the General Anxiety Disorder 7-item (GAD-7) scale), with a treatment arm mean of 3.16 compared to Control arm mean of 4.99, (LS Mean Differences -1.83, (95% CI, -2.41, -1.25); p<0.0001), and suicidal ideation (as measured by the Psychiatric Symptom Frequency Scale), with a treatment arm mean of 0.51 compared to control arm mean of 0.80, (LS Mean Differences -0.29, (95% CI, -0.53, -0.06), p = 0.0147). Results of the study were published in Lancet Psychiatry.

“Prescription digital therapeutics are a new treatment class that use software applications to directly treat serious disease. PDTs [prescription digital therapeutics] are designed to deliver evidence-based treatment anytime, anywhere, while also providing clinicians with real-time data on patient progress,” says Corey McCann, MD, PhD, president and CEO of Pear Therapeutics. “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.”

Somryst is the first product submitted to the FDA to test its Software Pre-certification 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 Pre-certification 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.