First ‘digital pill’ approved by US regulators

US regulators have approved a digital pill that lets doctors track its path through the body in order to know whether patients are taking their medication correctly.

The technology is able to record medication ingestion and communicate it to the patient and healthcare provider.

In addition, it can collect data on activity level, as well as self-reported rest and mood which, with patient consent, can be shared with the healthcare provider.

The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.

The FDA said that being able to track ingestion of medicines prescribed for mental illness may be useful “for some patients”, although the ability of the digital pill to improve patient compliance had not been proved.

In addition, tracking ingestion during emergencies is not recommended as detection may be delayed or not occur.

“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,” said the FDA’s Mitchell Mathis.

The system works by sending a message from the pill’s sensor 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.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

Poor compliance with drug regimens is a common problem in many disease areas, especially when patients suffer from chronic conditions.

Andrew Thompson, president and chief executive officer of Proteus Digital Health said, “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 smart phones, as they go about their daily lives. 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.”

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