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jh-siesta.com December 11, 2017


FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

16 November 2017, 02:02 | Eugene Bates

FDA gives greenlight to first digital ingestion tracking system

FDA approves the first pill that can alert your doctor when you swallow it

Big news for the health industry: USA regulators have approved a pill that can be digitally tracked through the body using an ingestible sensor and a patch worn by patients.

Abilify MyCite is expected to hit the market next year, but the price has not yet been set. And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example. It can also be used in the acute treatment of manic and mixed episodes associated with bipolar I disorder so it has the potential to do a whole lot of good.

Before this Otsuka Pharmaceutical Co Ltd's established drug Abilify, equipped with sensors was given approval in 2012.

Ms Wells said advances that safely and economically supported patients in taking their medicine as prescribed had significant benefits to the patient and the health system in reducing the pain and costs of avoidable illness.

The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology.

The sensor activates when the pill gets wet in the patient's stomach.


The U.S. Food and Drug Administration has approved a digital pill for the first time today, paving the way for other forms of connected medicine that could shape the future of healthcare.

"With the patient's consent, this information could be shared with their health care 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", it said. Once ingested, the digital pill sends a wireless signal to the patch, which then transmits information to the app and to a companion web portal. Some studies have shown that around 50% of chronic disease patients in developed countries do not take their medication as prescribed. The FDA warns that Abilify MyCite should not be used to track drug ingestion "in real-time" or during an emergency, because detection may be missed or delayed.

It is not approved for use in elderly patients with dementia-related psychosis. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

The system can also "help remind people with schizophrenia if they forgot to take medications", Birnbaum said.

It's aimed at people who are being treated for schizophrenia and as an add-on treatment for adults suffering with depression. Tech developers and some health experts say that the systems will improve patient outcomes by helping patients stick to their meds and take them properly.



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