Pear Therapeutics’ digital insomnia therapeutic will put FDA’s PreCert framework through its paces (MobiHealthNews):
“Prescription digital therapeutics company Pear Therapeutics announced late last week that it has filed an FDA marketing authorization for Somryst, its digital cognitive behavioral therapy for the treatment of adults with chronic insomnia and depression.
While an approval from the agency would mark the third authorized prescription digital therapeutic for Pear — behind reSET for substance use disorder and reSET‑O for opioid use disorder — the Somryst application is also the first product to CEO and President Dr. Corey McCann’s knowledge submitted through the FDA’s Precertification Program’s Working Model … if cleared, Somryst’s digital nature could address the scaling and dependency issues that current treatments for chronic insomnia and depression face, McCann said.
“CBTi is currently mandated as first line treatment for insomnia, but it is very very difficult for patients to receive in the real world because clinicians just aren’t sufficiently trained nor are they [incentivized] to provide face-to-face therapy of this degree of rigor,” he said. “So you can think of this as fitting into a paradigm for treating chronic insomnia as a first line treatment, and I think this is in very nice contrast to pharmacotherapies for insomnia. Things like zolpidem and benzodiazepines, which are better used in a short-term context, also have what is a habit-forming set of side effects and really don’t have the ability to provide a long-term clinical benefit as was demonstrated for Somryst.”
But along with the potential benefits of the treatment itself, Pear’s announcement serves as a progress report of sorts for the FDA’s experimental effort.”
News in Context:
- Pear Therapeutics raises $50M to develop and market a portfolio of digital therapeutics for mental health
- FDA clears first CBT-based digital therapeutic to treat substance abuse disorders
- The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation
- Five reasons the future of brain enhancement is digital, pervasive and (hopefully) bright
- The FDA warns consumers not to use unapproved apps and devices to diagnose concussion