U.S. ap­proves dig­i­tal pill to track pa­tients

Austin American-Statesman - - BUSINESS - By Matthew Per­rone

U.S. reg­u­la­tors have ap­proved the first drug with a sen­sor that alerts doc­tors when the med­i­ca­tion has been taken, of­fer­ing a new way of mon­i­tor­ing pa­tients but also rais­ing pri­vacy con­cerns.

The dig­i­tal pill ap­proved Mon­day com­bines two ex­ist­ing prod­ucts: the for­mer block­buster psy­chi­atric med­i­ca­tion Abil­ify — long used to treat schizophre­nia and bipo­lar dis­or­der — with a sen­sor track­ing sys­tem first ap­proved in 2012.

The tech­nol­ogy is in­tended to help pre­vent dan­ger­ous emer­gen­cies that can oc­cur when pa­tients skip their med­i­ca­tion, such as manic episodes ex­pe­ri­enced by those suf­fer­ing from bipo­lar dis­or­der.

But de­vel­op­ers Ot­suka Phar­ma­ceu­ti­cal Co. and Pro­teus Dig­i­tal Health are likely to face hur­dles. The pill has not yet been shown to ac­tu­ally im­prove pa­tients’ med­i­ca­tion com­pli­ance, a fea­ture in­sur­ers are likely to in­sist on be­fore pay­ing for the pill. Ad­di­tion­ally, pa­tients must be will­ing to al­low their doc­tors and care­givers to ac­cess the dig­i­tal in­for­ma­tion.

These pri­vacy is­sues are likely to crop up more of­ten as drug­mak­ers and med­i­cal de­vice com­pa­nies com­bine their prod­ucts with tech­nolo­gies de­vel­oped by Sil­i­con Val­ley.

The new pill, Abil­ify MyCite, is em­bed­ded with a dig­i­tal sen­sor that is ac­ti­vated by stom­ach flu­ids, send­ing a sig­nal to a patch worn by the pa­tient and no­ti­fy­ing a dig­i­tal smart­phone app that the med­i­ca­tion has been taken.

The FDA stressed how­ever that there are lim­i­ta­tions to mon­i­tor­ing pa­tients. “Abil­ify MyCite should not be used to track drug in­ges­tion in ‘real-time’ or dur­ing an emer­gency,” the state­ment said.

The Ja­panese drug­maker has not said how it will price the dig­i­tal pill. Pro­teus Dig­i­tal Health, based in Red­wood City, Cal­i­for­nia, makes the sen­sor.

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