Digital Pill Technology Approved by FDA
Patients and doctors will soon have the ability to connect pills to personal devices. The FDA approval in November 2017 of Abilify My Cite pill has introduced a new era in prescription documentation. The Atlantic has reported that costs associated with not taking prescribed medicines are estimated at $100 to $289 billion USD a year in the USA alone. Patients incapable of complying with their prescriptions are the target consumers for the new technology.
Otsuka Pharmaceutical, the developers of the digital pill, has joined forces with Proteus Digital Health to collaborate on a pill sensor device. The sensor and medication can be used to treat adults diagnosed with schizophrenia, bipolar I disorder and depression. Included on the packaging and label is a clear note that the ability of the treatment to improve patient compliance has not been shown. However the pill was not designed to track real time ingestion and is rather deployed as a long term, misuse detection tool.
The medication aripiprazole is a standard treatment of the above disorders. The pairing of the drug with sensor technology will serve as a tool for mitigating non-compliant behaviour in patients. The target disorders generally affect patients by hindering their ability or desire to take their medications. The tablets are embedded with an Ingestible Event Marker (IEM) sensor which is responsible for recording the compliance data. For full function the sensor is remotely linked to a wearable patch sensor which connects to the MyCite app. The data can also be shared on web-based portals for healthcare providers and caregivers. Data recorded can include activity levels and can record self-reported moods.
The official release by Otsuka Pharmaceutical includes a list of warnings and dangers associated with the new technology. These warnings include closely related disorders that it cannot treat, the dangers associated with older age groups and the lack of data on pediatric applications. Aripiprazole the main ingredient in the pill has been approved since 2002, which allowed for quicker approval of the accompanying digital counterpart generally subject to different sets of medical development safety trials. The clinical trials for Abilify had shown side effects which include nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia, and restlessness. The Mycite patch had also induced irritation of the site of placement for some patients. The side effects found during trials only affected specific groups such as the elderly. The technology as a whole is already available however only through medical professionals requests directly to the pharma companies involved in its development.