US ap­proves dig­i­tal pill that tracks when pa­tients take it

Business Standard - - WORLD - VIB­HUTI SHARMA & BEN HIRSCHLER BLOOMBERG

US reg­u­la­tors have ap­proved the first dig­i­tal pill with an em­bed­ded sen­sor to track if pa­tients are tak­ing their med­i­ca­tion prop­erly, mark­ing a sig­nif­i­cant step for­ward in the con­ver­gence of health­care and tech­nol­ogy.

The medicine is a ver­sion of Ot­suka Phar­ma­ceu­ti­cal Co Ltd's es­tab­lished drug Abil­ify for schizophre­nia, bipo­lar dis­or­der and de­pres­sion, con­tain­ing a track­ing de­vice de­vel­oped by Pro­teus Dig­i­tal Health.

The sys­tem of­fers doc­tors an ob­jec­tive way to mea­sure if pa­tients are swal­low­ing their pills on sched­ule, open­ing up a new av­enue for mon­i­tor­ing medicine com­pli­ance that could be ap­plied in other ther­a­peu­tic ar­eas.

Shares in Ot­suka rose 2.5 per cent on Tues­day af­ter news of the US Food and Drug Ad­min­is­tra­tion (FDA) late on Mon­day.

The FDA said that be­ing able to track in­ges­tion of medicines pre­scribed for men­tal ill­ness may be use­ful "for some pa­tients", al­though the abil­ity of the dig­i­tal pill to im­prove pa­tient com­pli­ance had not been proved.

"The FDA sup­ports the de­vel­op­ment and use of new tech­nol­ogy in pre­scrip­tion drugs and is com­mit­ted to work­ing with com­pa­nies to un­der­stand how tech­nol­ogy might ben­e­fit pa­tients and pre­scribers," said Mitchell Mathis of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search.

The sys­tem works by send­ing a mes­sage from the pill's sen­sor to a wear­able patch, which then trans­mits the in­for­ma­tion to a mo­bile ap­pli­ca­tion so that pa­tients can track the in­ges­tion of the med­i­ca­tion on their smart­phone.

About the size of a grain of salt, the sen­sor has no bat­tery or an­tenna and is ac­ti­vated when it gets wet from stom­ach juices. That com­pletes a cir­cuit be­tween coat­ings of cop­per and mag­ne­sium on ei­ther side, gen­er­at­ing a tiny elec­tric charge.

In the longer term, such dig­i­tal pills could also be used to man­age pa­tients with other com­pli­cated medicine rou­tines, such as those suf­fer­ing from di­a­betes or heart con­di­tions.

Poor com­pli­ance with drug reg­i­mens is a com­mon prob­lem in many dis­ease ar­eas, es­pe­cially when pa­tients suf­fer from chronic con­di­tions.

Pro­teus has been work­ing on the pill track­ing sys­tem for many years and the sen­sor used in Abil­ify MyCite was first cleared for use by the FDA in 2012.

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