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FDA Approves Digital Pill
14 November 2017, 08:12 | Lena Norman
U.S. regulators have approved the first pill with a sensor, which can track whether or not patients have taken their medicine.
Abilify MyCite combines Otsuka's aripiprazole, a drug used to treat schizophrenia, bipolar disorder and depression, with an ingestible sensor produced by Proteus Health.
Once a patient swallows the pill a sensor sends a message to a wearable patch. "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". If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too.
But until now, the FDA had not approved a sensor-pill combination.
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. Labeling information stresses that it has not been proven if tracking such information improves treatment regimens.
The FDA approved Abilify in 2002 to treat schizophrenia, which affects about one percent of the USA population.
In a portion of the statement that appeared to address privacy concerns, the FDA said the wearable patch that comes with the medication "transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone". "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".
Always forget if you've taken your medication? Sometimes the system might not detect that the medication has been taken. For physicians, this information, assessed in collaboration with the individual, helps facilitate a more open dialogue. "Patients can discontinue sharing some information from the system, or opt out of the program altogether, at any time".
Abilify MyCite is not approved for treating patients with dementia-related psychosis.
"When patients don't adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly", Dr. William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center, told the Times. Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smartphones, as they go about their daily lives.
The FDA's approval does come with some conditions, though.
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