FDA Approves First Digital Pill

FDA Approves First Digital Pill

The new tech could be used by the judiciary to ensure that patients on parole or those in psychiatric wards take their meds, which could spark more ethical concerns.

Patients who are prescribed the product, called Abilify MyCite, have to agree that their physicians can see the data.

Abilify MyCite, a pill with the ingestible sensor, is approved for the use in patients with schizophrenia, bipolar I disorder and as an add-on treatment for depression, according to the FDA. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.

About the size of a grain of sand, the sensor activates when it comes into contact with stomach fluid.

Meanwhile, the patch detects and records the date and time when the tablet was detected in the stomach in addition to physiological data, such as the patient's activity level. Many people diagnosed with these conditions fail to take medication on their own.

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. It also says that "Abilify MyCite should not be used to track drug ingestion in "real-time' or during an emergency because detection may be delayed or may not occur".

The recently approved tech was first embedded in Abilify, a drug approved by the 2002 to help treat bipolar disorder, schizophrenia, and a depressive disorder. Appelbaum said. "You would think that, whether in psychiatry or general medicine, drugs for nearly any other condition would be a better place to start than a drug for schizophrenia".

FDA Approves First Digital Pill
FDA Approves First Digital Pill

Otsuka Pharmaceutical, which is a unit of Tokyo-based Otsuka Holdings Co., the drugmaker's parent company, plans to start the program with just a handful of health systems and gather evidence on the drug's effects on adherence, he said.

Jaffe said he worries if it'll cause providers to choose Abilify over other medications that may be better for a patient.

The "trackable pill" is equipped with a sensor that can notify a digital device on the patient's wrist if that patient has swallowed the medication.

The price of the pill and when the pill will be on the market are still not known.

The FDA approved the first generic versions of Abilify two years ago, and Gellad predicts that "the daily generic is going to be much less expensive than this one with the sensor".

Information about mental illness is particularly sensitive, said Savage, a former privacy officer at the Department of Human and Health Services.

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