FDA approves first ever ‘digital pill’

An innovative medical device, in the form of a pill containing a built-in sensor has been developed and been given approval, based on safety and efficacy data, by U.S. authorities.

by Tim Sandle

What is being heralded as the world’s first ‘digital’ pill has gained approved by the U.S. Food and Drug Administration (FDA). The pill is called Abilify MyCite. The pill contains a medication called aripiprazole, which treats conditions like schizophrenia, bipolar disorder and depression. Also combined with the pill is an ingestible sensor. The pill comes after several years of research and is a venture between the Japanese pharmaceutical company Otsuka and digital medicine service Proteus Digital Health.

It is the sensor that creates the ‘digital’ or ‘smart’ pill. The purpose of the sensor, according to The Verge, is to record when the pill has been taken. This happens by a signal being sent to a wearable patch (fixed to the left rib cage); and then from the patch to a mobile device such as a smartphone via Bluetooth. The patch has additional functionality. It records activity levels, sleeping patterns, steps taken, and heart rate. The patch needs to be replaced every seven days.

The purpose of this is to determine when a pill has been taken. This either acts as a reminder  to patients that they have (or to verify that they have not) taken their required dose of medication; or, for more serious cases where a patient has been sectioned as the result of a mental disorder, to enable medics to record the fact that a medication has been taken.

Failure to take medications has societal and economic consequences, such as putting a strain on the hospital system. According to Dr. William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center, who spoke with the New York Times on this subject: “When patients don’t adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly.”

The sensor is only the size of a grain of sand. It is manufactured from silicon, copper, and magnesium. In terms of how the sensor works, an electrical signal is activated when the sensor comes into contact with stomach acid.

It is a common problem with medications, either through forgetfulness or as a conscious act, when patients do not taken the medicines prescribed to them. The digital pill aims to redress this.

Commenting on the go-ahead for the digital pill to be marketed, Mitchell Mathis, who is the director of the Division of Psychiatry Products in the FDA, told PharmaPhorum: “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients.”

The regulator added: “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The agreement relates to both parts of the smart medication: Abilify and Proteus Health’s sensor and patch, for the U.S. market. A label warning will accompany the product. This will state that the combined smart system has not been shown to improve patient compliance and that there are concerns about the effectiveness of the tracker in real-time since detection may be delayed. Nevertheless, the digital pill is likely to become popular with the medical establishment. The price of the pill has yet to be announced.

The Wall Street Journal opines that there could now be a raft of approval requests for other digital pills. The paper also notes that the FDA are preparing to hire more staff with understanding of software development in relation to medical devices.