The U.S. Food and Drug Administration said Tuesday it has approved Abilify MyCite (aripiprazole tablets) that has an ingestible sensor that records the medication was taken, the first drug in the U.S. with a 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.
Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
It might sound creepy, but U.S. regulators have approved a drug that can digitally track whether patients have taken their medicine.
"Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur", the FDA news release said. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.
In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.
Patients wear a patch over their torso, which relays a signal between the drug pill and the mobile app.
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. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. However, Abilify MyCite's own prescription labeling says it still hasn't been shown the drug improves "patient compliance" with their treatment, according to the FDA.