This Digital Pill Can Track Patient's Medication Usage

Brandon Parsons
November 15, 2017

On Nov. 13, 2017, FDA announced it has approved Abilify MyCite (Otsuka Pharmaceutical Co., Ltd.), which is the first drug in the United States that has a digital ingestion tracking system.

The system sends a message from the pill's sensor to a wearable patch.

Dr. Mitchell Mathis of the FDA says officials support "use of new technology in prescription drugs and is committed to working with companies to understand how the new technology might benefit patients and prescribers".

And Otsuka is aware that Abilify MyCite is a more complicated product than the usual pill, and it'll be more hard to market, too. And the drug shouldn't be used in an attempt to track "real-time" ingestion, since detection could be delayed, the agency added. Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.

A new digital version of Abilify is the first-ever pill to notify patients that they've swallowed it.

Aripiprazole tablets are prescribed for serious mental conditions, such as schizophrenia and mania.

The Abilify MyCite approval is a bigger breakthrough for Proteus, which has been working on drug-device combo pills for years.

Abilify MyCite is not approved for patients with dementia-related psychosis; it has a Boxed Warning that taking this medication puts patients with dementia-related psychosis at an increased risk of death. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

In the case of Abilify, a patient who doesn't stick to the drug could end up in a psychiatric hospital, so Abilify MyCite may find its niche.

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. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. This first USA approval could bode well for other new products in the works, including sensor-embedded versions of generic blood pressure pill lisinopril and the standard diabetes drug metformin. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.

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