Washington, Nov 14: The US Food and Drug Administration (FDA) has approved the first drug in the US with a digital ingestion tracking system that can tell doctors whether the medication was taken.
It has an ingestible sensor embedded in the pill that records that the medication was taken.
The product, Abilify MyCite (aripiprazole tablets with sensor), was approved on Monday for the treatment of schizophrenia, bipolar disorder and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill's sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone, the FDA said in a statement.
Patients can also permit their caregivers and physician to access the information through a web-based portal.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Mitchell Mathis, Director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
Schizophrenia is a chronic, severe and disabling brain disorder. Typically, symptoms are first seen in adults younger than 30 years of age.
Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.
Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.
The approval of the so-called digital pill is expected to increase adherence to medication.
Prior to initial patient use of the product, the patient's health care professional should facilitate use of the drug, patch and app to ensure that the patient is capable and willing to use the system, FDA said.
"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," Mathis said.