The Food and Drug Administration (FDA) issued a first-of-its-kind approval on Monday, approving the first drug in the United States with a digital ingestion tracking system. The new pill, called Abilify MyCite, contains an ingestible sensor that can help patients (and their doctors and caregivers) keep track of whether they are taking their medication as directed.
Abilify MyCite is approved for the treatment of schizophrenia and bipolar I disorder, and as an add-on treatment for depression in adults.
The tiny sensor used in the new pill was first approved by the FDA in 2012 and has since been available for pharmacies to place inside a capsule along with other medications. In recent years, clinical trials have used the sensor to track patient compliance with medications for conditions like high blood pressure and type 2 diabetes.
Now, however, the technology has been integrated directly into a pill and can be marketed—along with a wearable patch and a mobile application—for the treatment of specific health conditions. The drug Abilify is also available as a generic (aripiprazole), but only the brand-name product will be available with a sensor.
People who already take Abilify and switch to Abilify MyCite will not notice anything different about how the drug works to treat their symptoms, the FDA said in an email to TIME. Once ingested, the digital pill sends a wireless signal to the patch, which then transmits information to the app and to a companion web portal. The patch runs on a tiny battery, while the sensor itself—about the size of a grain of sand and made of ingredients found in food—is powered by fluids in the stomach.
People who meet the criteria for Abilify MyCite can decide, along with their doctors and caregivers, whether this type of medication monitoring might help them manage their disease. They can also indicate through the app which members of their care team have access to information about their medication ingestion, activity and self-reported mood and rest.
Studies have not yet shown whether the addition of a digital tracking system will improve how well people comply with their medication regimen. The FDA warns that Abilify McCite should not be used to track drug ingestion “in real-time” or during an emergency, because detection may be missed or delayed.
Beginning in 2018, the launch of Abilify MyCite “will be conducted in close collaboration with only a select number of health plans and providers,” according to a joint press release from Proteus Health Systems, the makers of the pill’s digital sensor, and Otsuka Pharmaceutical Co., the maker of Abilify. A price for the drug has not yet been established.
Before prescribing the new pill and tracking system, doctors should ensure that their patients are capable of and dedicated to using the system, says the FDA. The drug Abilify (with or without the digital sensor) can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements. The MyCite stick-on patch may cause skin irritation in some people.
Abilify MyCite’s safety has not been established in children and adolescents. And because elderly people with dementia-related psychosis are at increased risk of death when taking antipsychotic drugs, the drug is not approved in this population, either.
Failing to stick to a regular medication regimen is a common problem, particularly for people with serious mental health issues, says Dr. Dolores Malaspina, director of the psychosis program at the Ichan School of Medicine at Mount Sinai. “Many of these people do not recognize that they have a disorder, or they don’t like the side effects of medication, or they stop taking it once they feel better,” she says. “And those things would not really be addressed by a pill with a sensor,” she adds.
But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take—or forget if they’ve taken—their medication for the day. “For those reasons, a device like this could indeed be very helpful, and I think it should be applauded,” Malaspina says.
She is also hopeful that the same technology could soon be offered in other types of drugs as well. “For many people who have to go into assisted living or nursing homes, the tipping point is that they can’t keep track of their medication,” she says. “This could be an amazing intervention for individuals and their families that would allow them to check in every day or two, without having to go to a higher level of care.”
But the advent of digital drugs also raises concerns about patient privacy and coercion. “Many people with schizophrenia or bipolar disease are ordered by the courts to take their medication,” says Malaspina. “The fact that someone might use this computer readout to decide if you are compliant—and that could affect your degree of freedom in society—is an issue that needs to be discussed and debated,” she says. “I see a difference in using this technology to help people comply, as many people want to, versus a way to have families or the courts scrutinize their behavior.”