This is the first drug in the United States with a digital ingestion tracking system.
Abilify MyCite comes in the form of a pill, outfitted with what's called an Ingestible Event Maker (IEM). The pill is embedded with a tiny sensor about the size of a grain of sand that lets doctors know if and when a patient has taken their medication.
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.
In prescribing Abilify MyCite, physicians must make sure patients download the corresponding mobile application on their smartphones and are comfortable using it, since that is how they will ultimately view the information provided from the drug-device combo.
Children, adolescents and young adults taking antidepressants are at an increased risk of suicidal thinking and behavior. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.
The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the us healthcare system an estimated $200 billion per year.
Abilify MyCite is not approved for treating patients with dementia-related psychosis. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.
Before a patient uses Abilify MyCite for the first time, clinicians must facilitate use of the medication, patch, and system to ensure the patient is able and willing to use it.
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.
Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia.
In a statement on Monday, the FDA said that the digitally-enhanced drug "works by sending a message from the pill's sensor to a wearable patch".