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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.”

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