FDA approves first drug in U.S. with digital ingestion tracking

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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.

USA regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

Schizophrenia drug Abilify MyCite becomes the first drug approved in the US with a sensor that digitally tracks if patients have ingested their medication.

The drug is approved for the treatment of bipolar I disorder characterized by the occurrence of at least one manic or mixed episode, schizophrenia, and add-on treatment for depression in adults. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too.

Abilify MyCite contains a Boxed Warning to alert healthcare professionals not to treat patients with dementia-related psychosis. Patients should be monitored for worsening and emergence of suicidal thoughts and actions. Abilify MyCite is not approved to treat patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.

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.

The FDA approval came with some caveats regarding the technology's limitations, though.

Abilify on its own had received FDA's approval in 2002 for the treatment of schizophrenia. The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole marketed by Otsuka Pharmaceutical.

Proteus has been working on the pill tracking system for many years and the sensor used in Abilify MyCite was first cleared for use by the FDA in 2012.

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