Silver Spring, Maryland—(ENEWSPF)—November 14, 2017
By: Rosemary Piser
Today, the Food and Drug Administration (FDA) approved the first U.S. drug with a digital ingestion tracking system. The drug, Abilify MyCite (aripiprazole tablets with sensor), contains an ingestible sensor embedded in the pill that records that the medication was taken. Abilify MyCite is approved for use for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with certain bipolar disorders and as an add-on treatment for depression in adults.
Abilify Mycite sends a message from the pill’s sensor to a patch worn by the patient. The patch then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research 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.”
It is important to point out that according to the Abilify MyCite’s labeling information, the ability of the drug to improve patient compliance with their treatment regimen has not been shown. As a result, the FDA points out that Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.
The FDA first approved Abilify in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.
The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.
The FDA’s complete report on today’s announcement can be found here.