FDA Approves First Pill With Digital Tracking System

RUNSTUDIO  Getty Images

RUNSTUDIO Getty Images

Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health. 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.

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.

Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently. The sensor, which has no battery or antenna, is activated when it gets wet from the fluids in the stomach, according to Reuters.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill has the potential to improve public health, but warned it could foster more mistrust if used improperly.

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The information can also be sent to the prescribing doctor, if the patient consents to this. Estimates suggest that 50% of patients with chronic conditions do not take their medications, costing the U.S. healthcare system upwards of $100 billion in avoidable costs.

Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed. The ingestible sensor used in it was granted marketing permission by the regulator in 2012. It comes as well with a Boxed Warning to alert healthcare professionals to the effects of antipsychotic drugs on elderly patients diagnosed with psychosis related to dementia, citing higher death risk. "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

The Boxed Warning also indicates that children, adolescents, and young adults may be at an increased risk of suicidal thoughts and behaviors.

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

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