FDA approves first 'digital pill' to track patients

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

FDA approves pill with digital ingestion tracking system

Each MyCite pill comes with a tiny ingestible sensor that communicates with a wearable patch placed on the patient's skin, which itself communicates with a smartphone app. Patients can also allow their physicians and caregivers access to their data through the internet.

This technology might work better for different medications, like antibiotics where it's crucial that the patient finish the dose, or medication for elderly patients who might need help remembering to take their pills.

Abilify MyCite is used for the treatment of schizophrenia, manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults.

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement. Some studies have shown that around 50% of chronic disease patients in developed countries do not take their medication as prescribed.

The Centers for Disease Control and Prevention estimate that "one half of patients in the USA stop taking their medications within one year of being prescribed".

The Abilify pill was first approved by thee Food and Drugs Administration (FDA) back in 2002, to treat schizophrenia and the sensor technology was approved for marketing in 2012.

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Otsuka Pharmaceutical and Proteus Digital Health, which jointly make Abilify MyCite, said in a news release Monday night that the pill is a logical advance in today's high-tech, connected world. According to the California-based digital medicine company, the sensor is made of elements "found in a typical diet". A resubmission of the new drug application was accepted by the agency in May 2017. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. Patients can also grant healthcare providers access to the information through an online portal. Typically, it can take anywhere between 30 minutes and two hours for pill ingestion to be detected.

Otsuka explains, "The system has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialogue with their healthcare team".

Pills with digital tracking systems are said to be under consideration for other conditions.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", says Mitchell Mathis, M.D., Director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

The system could be used to manage patients who have long, complex medical routines in the future.

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