Smart drugs that can alert doctors if patients stop taking them have taken a major step forward.

California-based Proteus said the US Food and Drug Administration has agreed to review its device, which is embedded in a schizophrenia medicine called Abilify.

Researchers say the technology could be especially useful in mental illnesses and memory disorders such as schizophrenia and Alzheimer's where compliance is particularly poor.

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Researchers say the technology could be especially useful in mental illnesses and memory disorders where patients often don't take their medication. The pill looks identical to a normal drug, and communicates with a patch (seen on table).

HOW IT WORKS When the pill is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach and reacts with acid there. The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers. Patients view the information using a secure and local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals. Advertisement

Researchers say it could help ensure patients stick to their prescriptions and so reduce wasteful spending on drugs that are not taken properly.

An estimated 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, limiting the effectiveness of those medicines.

In the U.S., this may result in an estimated $100-300 billion in avoidable healthcare costs due to direct costs such as unnecessary escalation of treatment as well as indirect costs.

'Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression,' said William Carson, of Otsuka, which makes the drug.

'We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population.

'We look forward to continuing working with the FDA throughout the NDA review.'

If approved by the FDA, healthcare professionals will have the ability to prescribe tablets with the Proteus ingestible sensor embedded in the tablet.

'Digital Medicines have the potential to move healthcare beyond the proven efficacy of a medicine to understand the real world effectiveness of a therapy for each individual,' said Andrew Thompson, president and CEO of Proteus Digital Health.

'This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices.'

Researchers say the technology could be especially useful in mental illnesses and memory disorders where patients often don't take their medication.

It is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response.

The tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.

When abilify with the embedded ingestible sensor is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach.

The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns.

This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers.

Patients view the information using a secure and local software application on their mobile phone or device.