FDA approves first digital pill

Leslie Hanson
November 14, 2017

USA regulators have approved the use of a "digital pill" that tracks if a patient has taken their medication.

The drug is a version of established drug Abilify for schizophrenia, bipolar disorder and depression. The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times.

Shares in Otsuka rose 2.5 percent on Tuesday after news of the U.S. Food and Drug Administration (FDA) late on Monday.

Abilify on its own had received FDA's approval in 2002 for the treatment of schizophrenia.

The information can also be sent to the prescribing doctor, if the patient consents to this.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, and was subsequently rejected, with a request from the FDA for more information on the digital drug. The ingestible sensor used in it was granted marketing permission by the regulator in 2012. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.

The ability to track ingestion of the medication is meant to cut back on medical waste while improving adherence, although data to support this are lacking for Ability MyCite, according to the FDA.

The Times reported, though, that experts estimate that nonadherence or noncompliance to medication costs about $100 billion a year mostly because patients get sicker and need additional treatment.

The pill should not be used to track digestion in "real time" or during an emergency, as detection could be delayed or faulty, the FDA warned.

The pills are not licensed to be used in elderly patients with dementia-related psychosis.

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. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation. The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.

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