Pear Therapeutics nets digital pre-cert clearance for its insomnia-treating app

Expanding the reach of its digital therapeutic programs from substance abuse disorders to insomnia, Pear Therapeutics has received a new FDA clearance for its neurobehavioral app aimed at chronic sleeplessness.

The former Fierce 15 winner is collecting a number of firsts: Pear describes Somryst as the first prescription digital therapeutic for insomnia as well as the first digital product to be simultaneously reviewed under the FDA’s software precertification program.

Pear is one of nine companies participating in the agency’s multiyear digital health pilot, designed to streamline the regulatory process by focusing on assessing the developer itself in addition to their eventual individual products.

The company underwent the program’s first “excellence appraisal” in May 2019, where FDA staff visited the site and evaluated Pear’s workflow and company culture for commitments to product quality, clinical patient safety and cybersecurity responsibilities, among other metrics.

This allows for a simpler review process for digital products that can be updated and iterated faster than the traditional medical devices under the agency’s purview.

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“Now, more than ever, easily-accessible treatment options are imperative for patients suffering from chronic conditions,” President and CEO Corey McCann said in a statement. “Pear has built the capabilities, pipeline, and platform to allow us to build [prescription digital therapeutics] that help patients across a variety of disease areas.”

Somryst is built to provide first-line neurobehavioral interventions tailored specifically to its user, including guideline-recommended cognitive behavioral therapy aimed at insomnia, which affects more than 30 million adults. This includes a sleep restriction plan, scheduled by the app’s algorithms, over a longer period of time than can be managed with medications.

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Pear’s previous offerings, reSET and reSET-O, provided cognitive behavioral therapy for substance abuse and opioid use disorders, respectively.

Somryst’s approval was also supported by two randomized controlled trials, enrolling more than 1,400 participants. One study showed meaningful improvements in the amount of time it took for a person to fall asleep as well as their time spent awake at night after six and 12 months. The other showed reductions in insomnia severity measures after nine weeks.