Pear Therapeutics received marketing authorization for its third product — a digital therapeutic intended to treat chronic insomnia. Called Somryst, the app is available by prescription only. It consists of a nine-week program that includes cognitive behavioral therapy and restricting sleep to a limited window of time.

“The FDA’s authorization of our third (prescription digital therapeutic), Somryst, demonstrates our ongoing commitment to redefine disease treatment through the development of PDTs,” Pear Therapeutics CEO Dr. Corey McCann said in a news 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.”

The company’s submission included data from two randomized controlled trials, including a study of 1,100 adults reporting chronic insomnia that used Somryst for nine weeks. They saw a significant reduction in insomnia and depression severity that continued over an 18-month period.

Somryst was submitted for approval through the FDA’s traditional 510(k) pathway for medical devices, as well as the FDA’s new software precertification pilot program, intended to streamline the approval process for software-based medical devices.

The idea behind the pilot program is to look first at the developer behind the software, which could make it easier for them to get future approvals. In May, Pear underwent the first excellence appraisal as part of the program, which included an onsite evaluation of its product quality, cybersecurity responsibility, patient safety and other criteria.

Pear Therapeutics previously gained approval in 2017 for its reSET digital therapeutic, for the treatment of substance use disorder, and later for reSET-O, its product for the treatment of opioid use disorder.

While gaining approval is a milestone of its own, it’s still not enough to ensure a digital therapeutic’s success. Companies must also bring on pharmaceutical partners and develop a product physicians are willing to prescribe. While Pear has an advantage over the competition in that its products are backed by randomized clinical trials, physicians and health plans are still working out how to prescribe and pay for digital therapeutics.

Pear had a partnership with Sandoz, Novartis’ generics business, to commercialize its reSET therapeutic. But in late 2019, that agreement unraveled after Sandoz shuffled its leadership, though Novartis remains an investor in Pear.

More recently, the company struck an agreement with Ironwood Pharmaceuticals, a developer of GI medications, hinting at future therapeutics to come. Pear and Ironwood would evaluate digital therapeutics as a potential treatment for gastrointestinal conditions.

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