US FDA approves first drug with digital ingestion tracking system

The drug Abilify was first approved by the FDA in 2002 to treat schizophrenia, and the ingestible sensor, made by Proteus Digital health, was approved for marketing in 2012. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, M.D., the director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a statement.

The patch then transmits the information from the sensor to a mobile application so individuals can track the ingestion of the medication on their smartphone. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too.

Experts hope it could improve medication compliance, although the company that makes the tablets says this has not been proved for their product.

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.

FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge. The product includes a boxed warning noting that older adults with dementia-related psychosis treated with antipsychotic drugs are at a higher risk of death. The FDA advises that patients should be monitored for this condition.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may also occur.

According to The New York Times, medical noncompliance costs the United States $100 billion annually, mainly because failure to adhere to treatment leads to sicker patients who often require expensive hospitalization. "This information allows the opportunity for an open dialogue with the patient", said John Kane, MD, SVP, Behavioral Health Services, Northwell Health.

"The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness", said Proteus CEO Andrew Thompson.

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