FDA approves first digital pill


"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.

There were some issues, however, with green-lighting the new digital version as while the system can track doses, it hasn't been shown to improve patient compliance, said the FDA.

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.

This patch then transmits the information to a mobile app, so that a doctor and up to four caregivers, friends or family members can see the information through a web-based portal. About 1 percent of Americans have this illness.

Schizophrenia is a chronic, severe and disabling brain disorder, and its symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn. The drug is now not approved to treat these patients, according to the FDA.

The drug contains a warning box for professional healthcare workers that elderly patients with dementia-related psychosis are treated with antipsychotic drugs. While the rates at which patients deviate from their treatment regimens vary, estimates hold such actions cost the USA healthcare system hundreds of billions of dollars each year.

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Abilify MyCite's future isn't certain, however. 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.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the USA each year in "caring for health conditions that are attributable to nonadherence".

The original Abilify pill, developed by Japanese drugmaker Otsuka Pharmaceutical, was first approved by the FDA in 2002 to treat schizophrenia, while the ingestible sensor technology, created by California-based Proteus Digital Health, was approved for marketing in 2012.

As explained in an FDA news release, the pill contains a sensor that communicates with a wearable patch.

The decision approves the Ability MyCite system as a whole - both Abilify and Proteus Health's sensor and patch had previously been cleared individually in the US.