Regulatory Affairs

US FDA approves first drug with digital ingestion tracking system

PBR Staff Writer Published 14 November 2017

Otsuka Pharmaceutical has secured approval from the US Food and Drug Administration for its Abilify MyCite (aripiprazole tablets with sensor), an antipsychotic drug that has an embedded sensor to digitally track if patients have ingested their medication.

The sensor in Abilify MyCite is ingestible and can also record when the patients had taken the pill.

Abilify MyCite has been approved for treating schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and also an add-on treatment for depression in adults.

According to the drug regulator, when a patient takes the pill, the sensor in it will transmit a message to a wearable patch, which in turn, delivers the details to a mobile application. Patients can monitor the drug ingestion on their smart phone.

Caregivers and physicians can also be permitted by the patients to get the information via a web-based portal.

California-based Proteus Digital Health had developed the sensor technology and patch used in the digital pill.

FDA Center for Drug Evaluation and Research, Division of Psychiatry Products director Mitchell Mathis said: “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients.

“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 drug regulator warns that Abilify MyCite should not be used for real-time tracking of drug ingestion or during an emergency as detection could be delayed or may not take place.

Abilify on its own had received FDA’s approval in 2002 for the treatment of schizophrenia. The ingestible sensor used in it was granted marketing permission by the regulator in 2012.

Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/