On Monday the Food & Drug Administration approved the first medicine in the US with a digital ingestion tracking system that works with a smart phone.
The newly approved pill is called Abilify MyCite, and it's created to sense when patients have taken their dose of Abilify, an antipsychotic that is commonly used to treat mental disorders such as schizophrenia and bipolar disorder. Furthermore, doctors and health care providers can get permission from their patients to access the drug tracking data through an online portal.
"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers".
While it's the first time the FDA has approved such a pill, various specialty pharmacies and hospitals in the USA have previously "packaged" various drugs and sensors.
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The FDA noted that Abilify MyCite has not demonstrated an ability to improve patient compliance; therefore it should not be used to track medication ingestion in real-time or during an emergency, as detection may be delayed or may not occur.
The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues.
When the pill is swallowed, a tiny sensor in the pill sends a message to a wearable patch.
It might sound creepy, but United States regulators have approved a drug that can digitally track whether patients have taken their medicine.
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The FDA hopes the new pill will help ensure patients with mental disorders will take their medication.
Experts say the technology could be a useful tool but it will also change how doctors relate to their patients. And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year. It's also been approved as a supplemental treatment for adult depression.
Andrew Thompson, president and chief executive officer of Proteus, said in a news release that "consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones". However, Abilify MyCite is the only version now approved with the digital tracking system.
Nevertheless, the regulatory approval is a big win for Proteus, which has been promoting its self-tracking pill technology as a way to help patients take their medicine as prescribed.
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