United States approves digital pill that tracks when patients take it (4578, MDT)

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

Abilify MyCite (aripiprazole tablets with sensor) has been approved for use in the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. Then, before it disintegrates, it sends a signal to a patch the patient wears on their abdomen, which sends a signal to an app that patients or doctors can track.

On Monday, the FDA said the digital drug pill might be useful for some patients.

The drug - Abilify MyCite, developed by Otsuka Pharmaceutical will help to keep a track of patients, and whether they are taking the prescribed medicines in time or not.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency", the statement said, "because detection may be delayed or may not occur".

"The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness", said Andrew Thompson, president and chief executive of Proteus Digital Health.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

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In 2014, the World Health Organisation (WHO) reported that around 50 percent of patients on prescription medications do not take their drugs as directed. In cases where it's vital ifor patients to take a medication on a regular schedule, a digital pill would allow a physician to be alerted to a missed dose.

This sensor is the "size of a grain of sand, and is made up of ingredients found in food", according to Otsuka.

Andrew Thompson, president and chief executive officer of Proteus, said in a news release that "consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones". And as with most technological steps forward, it also raises questions about privacy, bioethics, and the use of big data from inside your body.

But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take-or forget if they've taken-their medication for the day. Ensuring that a patient is actually taking their meds has, up to now, relied on the word of the patient, but the honor system is about to go the way of the dodo thanks to a new "digital pill" technology that can actually track whether or not you're sticking to the doctor's orders.

The Wall Street Journal reports that the FDA is anticipating a potential raft of approval requests for other digital pills.

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