Tech

The FDA has approved the first digital pill

The FDA has approved the first digital pill

In what could be a game changer in health industry, the Food and Drug Administration has approved the first ever drug tracker pill.

Otsuka said that the pairing of the sensor with the antipsychotic Ability was created to allow patients with schizophrenia, bipolar I disorder or major depressive disorder to better track their daily medication intake and share that with their care team - which they can control through the linked app. The sensor works by sending a message from the pill to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. Doctors having knowledge of the frequency and use of a patient's medication can help with understanding why a prescription is working or not and ensuring proper dosages are set.

Abilify without sensor technology was first approved to treat schizophrenia in 2002.

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the US healthcare system an estimated $200 billion per year.

It might sound creepy, but USA regulators have approved a drug that can digitally track whether patients have taken their medicine.

Abilify MyCite, a form of aripiprazole and a first-of-its-kind product, has an embedded ingestible sensor that records when the medication is taken.

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In a statement issued last May at the time the FDA accepted submission of the product for review, the companies said "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".

Teens and young adults who are taking antidepressants are at increased risk of suicidal behavior and thoughts when taking the medication, cautions a boxed warning; they should be monitored closely.

The Abilify MyCite features a sensor the size of a grain of sand made of silicon, copper, and magnesium. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year. The agency also noted that the product has not shown an ability to improve patient compliance with a treatment regimen.

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.

But the digital pill hasn't yet been approved for use here.

The landmark approval is the latest in an expansive rethinking of what constitutes a treatment.


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