DTx

“Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy

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The effi­ca­cy of Men­tal Health Apps (phar­mafo­rum):

In Jan­u­ary, PLOS Dig­i­tal Health pub­lished a study which claimed that there’s “sparse” data to sup­port the effi­ca­cy of most men­tal health apps.

In their meta-analy­sis of pub­lished stud­ies, the authors found uni­ver­sal defi­cien­cies and con­clud­ed that there’s no con­vinc­ing evi­dence that app-based inter­ven­tions deliv­er mean­ing­ful out­comes. With­out dig­ging fur­ther, one might think the cur­rent case for dig­i­tal ther­a­peu­tics is weak.

I reviewed all 14 meta-analy­ses includ­ed in the study and found the analy­sis to be accu­rate, but incom­plete. [Read more…] about “Dig­i­tal ther­a­peu­tics” vs. “Men­tal health apps”: A grow­ing debate on stan­dards, reg­u­la­tion and efficacy

Pear Therapeutics raises $175M and goes public via SPAC deal raising the profile of prescription digital therapeutics

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Dig­i­tal health firm Pear goes pub­lic, rais­ing $175 mil­lion (phar­mafo­rum):

Pear will make its debut on the exchange today after com­bin­ing with Thim­ble Point – a spe­cial pur­pose acqui­si­tion com­pa­ny (SPAC) – in a deal that side­stepped the con­ven­tion­al ini­tial pub­lic offer­ing (IPO) route and has pro­pelled its val­u­a­tion to around $1.6 bil­lion … Pear spe­cialis­es in pre­scrip­tion dig­i­tal ther­a­peu­tics (DTx) based on cog­ni­tive behav­iour­al ther­a­py (CBT) tech­niques that can deliv­ered remote­ly to [patients via a dig­i­tal device. It has three apps approved by the FDA, includ­ing reSET and reSET‑O for peo­ple liv­ing with sub­stance and opi­oid use dis­or­ders, respec­tive­ly, and a tool for chron­ic insom­ni­acs called Som­ryst. [Read more…] about Pear Ther­a­peu­tics rais­es $175M and goes pub­lic via SPAC deal rais­ing the pro­file of pre­scrip­tion dig­i­tal therapeutics

Novartis dissolves agreement to market Pear Therapeutics’ prescription digital therapeutics for substance/ opioid abuse

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As San­doz returns mar­ket­ing rights for dig­i­tal ther­a­peu­tics to Pear, what does it mean for co-pro­mote arrange­ments? (MM&M):

“San­doz, the gener­ics divi­sion of Novar­tis, is alter­ing com­mer­cial course, return­ing mar­ket­ing duties for two pre­scrip­tion dig­i­tal ther­a­peu­tics (DTx) back to Pear Ther­a­peu­tics. The move, which some had antic­i­pat­ed, comes 18 months after the two signed a co-pro­mo­tion deal.

Since the Sandoz/Pear pact was wide­ly seen as a lit­mus test of sorts for pharma’s role in help­ing dis­trib­ute this nascent tech­nol­o­gy, the com­mer­cial break-up rais­es ques­tions about the via­bil­i­ty of such part­ner­ships going for­ward. It also high­lights the par­ties’ some­times con­flict­ing pri­or­i­ties: [Read more…] about Novar­tis dis­solves agree­ment to mar­ket Pear Ther­a­peu­tics’ pre­scrip­tion dig­i­tal ther­a­peu­tics for substance/ opi­oid abuse