US regulators have approved the world’s first digital medicine — a pill with an inbuilt sensor — opening up a new front in pharmaceuticals and the “internet of things”.
The tablet can be tracked inside the stomach, relaying data on whether, and when, patients have taken vital medication. The US Food and Drug Administration has given the green light for it to be used in an antipsychotic medication with the aim that the data can be used to help doctors and patients better manage treatment.
Poor compliance with drug regimes, particularly among sufferers of chronic diseases, is a pervasive problem for pharma companies and health systems, leading to lower consumption of the industry’s products and higher costs for payers when patients’ conditions deteriorate as a result of missing treatment.
The technology, developed over 10 years by Silicon Valley-based Proteus Digital Health, will be incorporated into an existing antipsychotic drug, Abilify, made by Japanese drugmaker Otsuka Pharmaceutical. The medication has been taken by about 7m people in the US since its launch 15 years ago.
Andrew Thompson, Proteus chief executive, said the technology would allow people with serious mental illness “to engage with their care team about their treatment plan in a new way”. Patients will be able to use a mobile phone to track and manage their medication.
He is already in talks with other major pharma companies about using the technology in treatments for various chronic conditions.
When patients swallow the tablet containing the sensor, a signal is sent to a patch worn on their bodies, which in turn connects to an app on their phones, showing that they have taken their dose. The doctor who has prescribed the medicine will automatically be sent the data and patients can also choose to nominate family and care team members to receive it.
The wearable patch will also be able to track how much patients are moving around — considered a key indicator of overall health — and allow them to self-report their mood and sleep quality via the app.
Kabir Nath, chief executive of Otsuka’s North American arm, said: “Non-adherence, which is an issue across all areas of chronic medicine, is a very specific issue in the area of serious mental illness. [It] can lead to dramatic healthcare consequences quickly in a way that it doesn’t always in other chronic healthcare conditions.”
Mr Nath said the drug would be given a “limited commercial rollout” to determine the demand from patients with conditions such as schizophrenia.
He would not be drawn on the price compared with the traditional version of the drug, saying this was “something we have yet to determine”.
Some have suggested that the technology raises concerns about data security but Mr Thompson said the system was designed “in a way that means it’s completely private; the information stays in your body. It never goes outside of your body; it only goes to the patch.”
The information was encrypted before being sent to patients’ phones, he added.
Some specialists in bioethics have questioned whether the digital medicine could be used coercively, on people in hospital against their will or as part of probation conditions, for example. But Otsuka said: “We intend that this system only be used with patient consent.”
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