FDA Approves Digital Pill

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 pill has an embedded ingestible sensor that records when the medication is taken. Abilify MyCite treats schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and is also used as an add-on treatment for depression in adults.

The pill’s sensor sends a message to a wearable patch that transmits information to a mobile application, which allows patients, caregivers, and physicians to track the ingestion of the drug on a smartphone and through a web-based portal. The sensor and patch are made by Proteus Digital Health. Labeling information stresses that it has not been proven if tracking such information improves treatment regimens. Abilify MyCite also contains a boxed warning about the risks of antipsychotic drugs.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

Source: FDA