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16 November 2017, 02:01 | Yvette Williams
FDA gives greenlight to first digital ingestion tracking system
Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders.
In combination though, the Abilify MyCite system was rejected by the FDA in April previous year due to concerns over the possible impact of "human factors" on safety.
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 agency said it the first drug in the United States with a digital ingestion tracking system. Doctors having knowledge of the frequency and use of a patient's medication can help with understanding why a prescription is working or not and ensuring proper dosages are set.
The system works by sending a message from the pill's sensor to a wearable patch.
The tracker itself is really small, about the size of a grain of sand, and apparently made up of ingredients found in food.
The developer of the sensor and patch technology, Proteus Digital Health, joined forces with Otsuka Pharmaceutical Co., Ltd., which produces the schizophrenia drug Ablify, to develop the smart pill, and this is the first time such a device has been approved by the FDA.
Patients wear a patch over their torso, which relays a signal between the drug pill and the mobile app.
Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors.
Users of the app - including the patient, but also any authorised doctors or family members - can then check in on the patient's ingestion data, keeping direct tabs on the timely swallowing of oral medication in private like never before.
"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown". The FDA noted that product is not for use in emergency or real-time situations, as detection could be delayed or not occur. The drug Abilify (with or without the digital sensor) can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements.
Experts say the technology could be a useful tool, but it will also change how doctors relate to their patients as they're able to see whether they are following instructions. However, the medication is geared only for people diagnosed with certain kinds of mental illness.
The system can also "help remind people with schizophrenia if they forgot to take medications", Birnbaum said. A person who suffers from this mental disorder appears to be out of touch with reality.
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