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FDA Approves First Digital Drug

FDA Approves First Digital Drug by Otsuka Pharmaceutical


Orange County, CA - January 24th 2018 -  A historical first, The Food and Drug Administration (FDA) has approved a digital drug: a pill with an embedded sensor able to relay information pertaining to its consumption. Invented by Japanese company Otsuka Pharmaceutical, the drug was created to help patients who suffer from schizophrenia, bipolar disorder, and depression keep track of their medication routines. The recorded data obtained by the drug can be shared with multiple users, such as a family members or a caregiver.

The tablet and embedded sensor is named Abilify MyCite, a sequel to the antipsychotic drug Abilify. Once ingested, the sensor activates upon contact with stomach fluids recording the date and time the pill was taken and then transmitting that data to a patch worn on the patient’s abdomen. The patch then sends the data to a smartphone app that can be shared with others. The drug aims to address a real and expensive problem patients struggle with nonadherence, or patients failing to comply with prescribed treatment.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research in a press release. "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." The FDA noted in the release that Abilify MyCite’s labeling states the product hasn’t been shown to improve patients’ compliance with their treatment regimen. However, the creators are hopeful the new tracking data will empower doctors to follow along with their patients’ medication timeline. 

Abilify MyCite, a sequel to the antipsychotic drug Abilify is equipped with an embedded sensor

Health experts were taken aback that the first FDA approved digital drug was an antipsychotic, for a portion of patients taking this medication live with schizophrenia. Experiencing paranoia and living in fear of being watched, taking this bodily data transmitting pill for others to survey may prove undesirable to these patients.

"Many of [these] patients don't take meds because they don't like side effects, don't think they have an illness, or they become paranoid about the doctor or their intentions," Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University's psychiatry department, told The New York Times. "A system that will monitor behavior, send signals out of [the patient’s] body, and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia,” Dr. Appelbaum said.

Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, is largely optimistic about the built in sensor technology, but has concerns about privacy. "We've seen time and time again that stuff that's being transmitted ends up in the hands of people it shouldn't," Gellad says. "There are real concerns about data security."

The price of Abilify MyCite has yet to be made public; time will tell if this controversial drug finds its place among the pharmaceutical market. 


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FDA Approves First Digital Drug


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