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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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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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