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FDA clears first CBT-based digital therapeutic to treat substance abuse disorders

reSET® for Sub­stance Use Dis­or­der. Image Cred­it: Pear Ther­a­peu­tics


The FDA just approved the first app for treat­ing sub­stance abuse (CNBC):

The app, devel­oped by a start-up called Pear Ther­a­peu­tics, is designed to be pre­scribed by clin­i­cian and used along­side coun­sel­ing.

Pear’s tech­nol­o­gy dig­i­tizes a form of talk ther­a­py called cog­ni­tive behav­ioral ther­a­py, or CBT, which focus­es on “exam­in­ing the rela­tion­ships between thoughts, feel­ings and behav­iors”, accord­ing to the Nation­al Alliance on Men­tal Ill­ness.

Stud­ies have found that CBT is an effec­tive treat­ment for sub­stance use dis­or­ders, and recent research sug­gests that it can be admin­is­tered online via a desk­top or mobile app. Abuse of tobac­co, alco­hol and illic­it drugs costs more than $740 bil­lion annu­al­ly in the U.S. alone. Drug-relat­ed deaths have tripled since 2000, accord­ing to the Nation­al Insti­tute on Drug Abuse…As part of the approval process, which McCann said took sev­er­al years, the FDA also cre­at­ed a new clas­si­fi­ca­tion for dig­i­tal ther­a­peu­tics that are deemed low to mod­er­ate risk. That will like­ly make it eas­i­er for oth­er apps to fol­low suit. Cur­rent­ly, dig­i­tal ther­a­peu­tics are being devel­oped to help treat insom­nia, opi­oid depen­dence, chron­ic dis­ease and more.”

FDA per­mits mar­ket­ing of mobile med­ical appli­ca­tion for sub­stance use dis­or­der (FDA news release):

Today, the U.S. Food and Drug Admin­is­tra­tion per­mit­ted mar­ket­ing of the first mobile med­ical appli­ca­tion to help treat sub­stance use dis­or­ders (SUD). The Reset appli­ca­tion is intend­ed to be used with out­pa­tient ther­a­py to treat alco­hol, cocaine, mar­i­jua­na and stim­u­lant SUDs. The appli­ca­tion is not intend­ed to be used to treat opi­oid depen­dence.

This is an exam­ple of how inno­v­a­tive dig­i­tal tech­nolo­gies can help pro­vide patients access to addi­tion­al tools dur­ing their treat­ment,” said Car­los Peña, Ph.D., M.S., direc­tor of the Divi­sion of Neu­ro­log­i­cal and Phys­i­cal Med­i­cine Devices in FDA’s Cen­ter for Devices and Radi­o­log­i­cal Health. “More ther­a­py tools means a greater poten­tial to help improve out­comes, includ­ing absti­nence, for patients with sub­stance use dis­or­der.”

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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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