The FDA clears Somryst, Pear’s digital therapeutic to treat chronic insomnia

Pear gets FDA clear­ance for insom­nia ther­a­peu­tic (Med­C­i­ty News):

“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 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 …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.”

News in Context:

• FDA clears first CBT-based dig­i­tal ther­a­peu­tic to treat sub­stance abuse disorders
• A call to action: We need the right incen­tives to guide eth­i­cal inno­va­tion in neu­rotech and healthcare
• New report: Empow­er­ing 8 Bil­lion Minds via Eth­i­cal Devel­op­ment and Adop­tion of Neurotechnologies
• CVS Health: Cog­ni­tive behav­ioral ther­a­py (CBT) apps may help you more than sleep­ing pills
• The FDA warns con­sumers not to use unap­proved apps and devices to diag­nose concussion
• 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