FDA clears Pear's digital insomnia therapeutic through 510(k), Pre-Cert pilot pathways

Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces.
By Dave Muoio
03:53 pm
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Pear Therapeutics announced this morning that Somryst, its prescription digital therapeutic for adults with chronic insomnia, has received marketing authorization from the FDA.

The treatment provides cognitive behavioral therapy for insomnia (CBTi) alongside personalized, algorithm-generated sleep restriction recommendations. The digital therapeutic was reviewed through the agency's 510(k) pathway and, notably, is also the first product to pass through the FDA's experimental Software Precertification Pilot Program.

Somryst's tailored CBTi is delivered over the course of nine weeks through a smartphone, tablet or similar device. It is intended to treat the symptoms of patients aged 22 years or older with chronic insomnia, and is only available by prescription from a licensed healthcare provider.

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Pear's regulatory submission was accompanied by two randomized controlled trials of the digital therapeutic, the company said in its announcement. The first, published in JAMA Psychiatry, measured six- and 12-month insomnia symptoms among 303 patients assigned the treatment or an active control. The second, published in Lancet Psychiatry, involved 1,149 patients, and demonstrated benefits over controls persisting as long as 12 months among those assigned the 9-week treatment.

While the company doesn't yet have a time line for when the product will hit the market, Dr. Yuri Maricich, Chief Medical Officer at Pear, said that Pear's goal is to follow a commercialization and distribution model roughly similar to those of its other two products, reSET and reSET-O. In this approach, a provider would send the prescription to Pear's "Patient Service Center," which staffs specialists who guide the patient through downloading the app through the App Store or Google Play Store, entering their prescription access code and then using the app-based therapy itself.

WHY IT MATTERS

CBTi is a listed as a first-line treatment for chronic insomnia in clinical guidelines from the American College of Physicians and the American Academy of Sleep Medicine alike. The downside, Maricich said, is that the demand for these behavioral health treatments greatly outstrip the 500 clinicians certified to provide CBTi in the U.S.

"The majority of patients aren't able to get treatment," he said. "Even if you are lucky enough to get [it], we often hear both from the clinicians, as well as patients, that they have a waiting list that oftentimes stretches beyond a year. So there's a really huge need."

As a digital treatment, Somryst can be easily scaled and delivered to patients who otherwise might have been prescribed a more traditional drug for their medication. With this in mind, he said that the company will be focusing on raising awareness of the product among a broad range of providers, and primary care doctors in particular.

"Primary care clinicians in general actually treat the bulk of chronic insomnia by volume, but typically because they haven't had good treatment options ... they'll just say, 'Well, why don't you take this pill for a little bit?' because they just don't have access," Maricich said. "I think the main point here is that there is going to be a broad group of clinicians who will now have something they can actually provide, that they know is the recommended [treatment]. That will just be part of [Pear's] overall approach: How do we make sure clinicians across specialty types know about it and have access?"

For Pear, Maricich said that Somryst clearance represents a major portfolio expansion beyond addiction treatment and into the broader neurobehavioral intervention space. For digital health at large, the digital therapeutic is now the first and only product put through the ringer of the Precertification Program's 1.0 Working Model.

Maricich spoke at length about what the Pre-Cert process was like for Pear and what others might expect when the pathway is opened to the public (check back with MobiHealthNews tomorrow for a full Q&A write-up). While the prescription digital therapeutics company's experience with the early Working Model and a simultaneous 510(k) was certainly atypical, he did note that the program's "Excellence Assessments" will likely be more expansive than some might be expecting.

"If a company was getting ready to go to an Excellence Appraisal and thought, 'Oh, we just need our quality people to show up, this is just an overview of our quality systems,' it was much larger than that," he said. "It was, writ large, what does high-quality software that impacts health look like? And, how do we think about that, not just from a quality perspective, but from a clinical perspective, from an organizational level around monitoring and refining our actual development process in an agile way to make the software better over time."

THE LARGER TREND

Pear announced that Somryst would be putting the FDA's experimental framework through its paces back in July, and was tapped to participate in the pilot as far back as 2017. The program itself was scheduled to conclude its one-year trial of the Working Model with the new decade, although the last update from the agency came with its six-month check-in during the summer.

Pear itself went through a bit of a shakeup last fall when its digital-therapeutics commercialization arrangement with Novartis' Sandoz came to an abrupt end. However, the company has been steadfast in its ability to commercialize and distribute its product without the pharma's support, and even announced a flurry of tech acquisitions around the start of the new year.

ON THE RECORD

“The FDA’s authorization of our third PDT, Somryst, demonstrates our ongoing commitment to redefine disease treatment through the development of PDTs,” Dr. Corey McCann, president and CEO of Pear Therapeutics, said in a statement. “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.”

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