Therapy Areas: Devices
Pear Therapeutics Obtains FDA Authorisation for Somryst Prescription Digital Therapeutic for the Treatment of Adults with Chronic Insomnia
30 March 2020 - - The US Food and Drug Administration has granted authorization for Somryst, the first prescription digital therapeutic intended for use in the treatment of patients 22 years of age and older with chronic insomnia, US-based Pear Therapeutics, Inc said.

Somryst treats patients with chronic insomnia by improving a patient's insomnia symptoms.

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 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-authorised therapeutic that delivers guideline recommended 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.

Somryst is the third PDT to receive authorization from the FDA, following Pear's reSET, and reSET-O. 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.

Somryst is a 9-week Prescription Digital Therapeutic for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet.

Somryst is available by prescription only. A licensed Health Care Provider must prescribe Somryst and use of Somryst should be undertaken only under the supervised care of a Health Care Provider.

Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia CBT-I) to patients 22 years of age and older with chronic insomnia.

Pear Therapeutics is in prescription digital therapeutics. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions.
Login
Username:

Password: