The US Food and Drug Administration (FDA) has approved the first digital pill, a medication embedded with a sensor that tracks if patients have taken their medication.

The pill, called Abilify MyCite, is a collaboration between Otsuka Pharmaceutical, manufacturers of Abilify, and Proteus Digital Health, a US-based company that created the sensor.

Abilify MyCite uses a sensor in combination with a version of Otsuka’s mental illness medication, Abilify, which is prescribed to treat schizophrenia, bipolar disorder and depression.

According to a statement issued by Proteus, the system provides an objective summary of drug ingestion over time, to help enhance collaboration with healthcare providers who treat patients with certain serious mental illnesses.

The FDA said that being able to track ingestion of medications prescribed for mental illness may be useful for some patients; however it has noted that the ability of the digital pill to improve patient compliance had not been proved.

“The approval of Abilify MyCite, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient’s illness management and personalised treatment plan,” said Senior Vice President for Behavioural Health Services, Northwell Health, John Kane, MD.

“This information allows the opportunity for an open dialogue with the patient. Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug,” continued Kane.

The digital pill is embedded with an ingestible sensor that communicates with a patch worn by the patient. The patch then transmits medication data to a smartphone app so that patients can track the ingestion of the medication. Patients can upload this information to a database which their doctor and other authorised persons can access through a web-based portal.

The sensor, which is about the size of a grain of salt and has no battery or antenna, is activated when it gets wet from stomach juices. The skin patch records the digital message, along with the patient’s heart rate, body angle and activity, and sends the data to a Bluetooth-enabled device such as a phone or computer.

Otsuka hasn’t indicated how much the digitised pills will cost, which will be rolled out next year first to a limited number of health plans and providers. The company will use the feedback it gets from the patients as they use the system daily and then enhance the product.

“The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness. Consumers already manage important tasks like banking, shopping and communicating with friends and family by using their smartphones, as they go about their daily lives,” said President and CEO of Proteus Digital Health, Andrew Thompson.

“With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way,” concluded Thompson.

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