August 31, 2020
Pear Therapeutics highlighted data today from two studies of a digital cognitive behavioral therapy that acted as the precursor for Somryst, the prescription digital therapeutic for adults with chronic insomnia that was the first to pass through the FDA's Pre-Cert pilot pathway.
The first, a randomized controlled trial of 1,149 Australian adults with insomnia and depressive symptoms, suggested...
(Photo by Jeff Schear/Getty Images for Kennedy Forum)
July 1, 2020
Over the last decade, the addiction and mental health space has becoming increasingly digital – so much so that the first prescription digital therapeutic, Pear’s ReSET, scored FDA clearance nearly three years ago. While more and more players begin to join the so-called "DTx" space, the technology is yet to hit the mainstream radar, but a new coalition is looking to change that.
A list of high-...
June 24, 2020
Digital therapeutics company Pear Therapeutics has inked a deal with pharmacy benefits manager (PBM) RemedyOne, allowing the latter to offer and administer benefit coverage for the formers’ prescription-addiction-focused therapies reSET and reSET-O to its customers.
Both reSET and reSET-O have FDA clearances. In fact, reSET was the first software-only therapeutic to get the designation. reSET ...
April 29, 2020
Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited distribution, after the FDA loosened up its regulations for digital psychiatric disorders devices during the coronavirus crisis.
The new tool, called Pear-004, uses multimodal neurobehavioral interventions combined with antipsychotic medications. Patients with schizophrenia can use the tool...
March 26, 2020
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)...
December 13, 2019
It has been a tumultuous week in the realm of digital health partnerships. It started with word of Proteus Digital Health’s floundering business and failed investment round, which reports say was partially driven by cooling relations between the digital pill maker and its longtime patron Otsuka Pharmaceuticals. A few days later, Sanofi announced a company-wide strategy shift that found Onduo, its...
October 16, 2019
Editor's Note: This story has been updated with additional quotes from Pear Therapeutics.
The poster child of digital therapeutics-pharma collaborations is soon to be no more, as Novartis division Sandoz announced that it is handing sole responsibility for the commercialization of the reSET and reSET-O prescription digital therapeutics back to Pear Therapeutics.
“Pear and Sandoz previously signed...
September 27, 2019
It’s been two years since the first software-only digital therapeutic got the FDA greenlight, but the industry is still very much in its infancy and continuing to evolve. New entrances are emerging from the world of health, pharma, tech and finance. As the industry matures, it's grappling with existential questions including regulation, reimbursement models and, as always, the definition of a...
July 22, 2019
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...
July 3, 2019
Diving deeper into digital, this quarter the pharma giants have continued to implement new tools to enhance clinical trials, support medication management with technology and partner in developing digital therapeutics.
Onc, a foreign entity to this established industry, pharma executives are now becoming better versed in working with digital health companies and sharing the lessons they've...