FDA ap­proves pill that can tell when it’s been in­gested

Abil­ify has sen­sor that sends mes­sage af­ter it reaches the stom­ach.

Los Angeles Times - - BUSINESS BEAT -

U.S. reg­u­la­tors have ap­proved the first drug with a sen­sor that can track whether pa­tients have taken their medicine.

The Abil­ify pill was first ap­proved by the Food and Drug Ad­min­is­tra­tion in 2002 to treat schizophre­nia, and the sen­sor tech­nol­ogy was ap­proved for mar­ket­ing in 2012. The FDA said Mon­day that the dig­i­tally en­hanced med­i­ca­tion “works by send­ing a mes­sage from the pill’s sen­sor to a wear­able patch.”

“Be­ing able to track in­ges­tion of med­i­ca­tions pre­scribed for ill­ness may be use­ful for some pa­tients,” Dr. Mitchell Mathis of the FDA said in a state­ment. “The FDA sup­ports the de­vel­op­ment and use of new tech­nol­ogy in pre­scrip­tion drugs and is com­mit­ted to work­ing with com­pa­nies to un­der­stand how this tech­nol­ogy might ben­e­fit pa­tients and pre­scribers.”

Abil­ify MyCite was de­vel­oped by Ot­suka Phar­ma­ceu­ti­cal Co., based in Ja­pan, and the sen­sor was cre­ated by Pro­teus Dig­i­tal Health, based in Red­wood City, Calif.

Green­light­ing the new dig­i­tal ver­sion, how­ever, came with some caveats. Al­though the sys­tem can track doses, it hasn’t been shown to im­prove pa­tient com­pli­ance, the FDA said.

“Abil­ify MyCite should not be used to track drug in­ges­tion in ‘real-time’ or dur­ing an emer­gency,” the agency said, “be­cause de­tec­tion may be de­layed or may not oc­cur.”

Pa­tients can track their dosages on their smart­phones and al­low their doc­tors or care­givers to ac­cess the in­for­ma­tion through a web­site.

In a state­ment is­sued in May when the FDA ac­cepted sub­mis­sion of the prod­uct for re­view, the com­pa­nies said that “with the pa­tient’s con­sent, this in­for­ma­tion could be shared with their health­care pro­fes­sional team and se­lected fam­ily and friends, with the goal of al­low­ing physi­cians to be more in­formed in mak­ing treat­ment de­ci­sions that are spe­cific to the pa­tient’s needs.”

The com­pa­nies said the sen­sor “ac­ti­vates when it reaches stom­ach flu­ids and com­mu­ni­cates with the patch.”

The FDA ap­proved dig­i­tal Abil­ify for the treat­ment of schizophre­nia, bipo­lar dis­or­der and as an add-on treat­ment for de­pres­sion in adults.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.