For the first time, self-tracking sensors can now be added to Abilify oral tablets, an antipsychotic medication for schizophrenia, bipolar disorder, depression and Tourette's, according to a Food and Drug Administration press release.
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. The pill called Abilify MyCite, is fitted with a tiny ingestible sensor that communicates with a patch worn by the patient - the patch then transmits medication data to a smartphone app which the patient can voluntarily upload to a database for their doctor and other authorized persons to see. At first techno-blush, concerns about Big Brother tapping one's body fall to the wayside; patients can voluntarily give access to the information gathered by the sensor to their doctor and designated family members or caretakers.
The path to FDA approval has not been without problems, and despite each individual element (the drug and the sensor) already being approved by the FDA separately, the approval process for the Abilify MyCite has been delayed by FDA queries about the product's use and safety.
The drug was made in collaboration with Otsuka Pharmaceutical and Proteus Digital Health, which designed the sensor. Doctors and health care providers have to get your permission first to track the data.much like those opt-in vehicle insurance tracking devices customers can get discounts for if they install the device in their cars. Patients prescribed opioid medication following surgery could be monitored to ensure they use them correctly, to head off dependence.
"With the patient's consent, this information could be shared with their health care professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs", it said.
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This technology might work better for different medications, like antibiotics where it's crucial that the patient finish the dose, or medication for elderly patients who might need help remembering to take their pills.
The technology carries risks for patient privacy too if there are breaches of medical data or unauthorized use as a surveillance tool, said James Giordano, a professor of neurology at Georgetown University Medical Center. Abilify MyCite is also not approved to treat older patients with dementia-related psychosis.
Abilify Mycite's prescribing information notes the ability of the product to improve patient compliance with their treatment regimen has not been shown. A person who suffers from this mental disorder appears to be out of touch with reality.
The Japanese drugmaker has not said how it will price the digital pill.
However, this approval is the first significant step emphasizing how healthcare and technology are beginning to converge.