FDA Approves First Drug with Ingestible Digital Adherence Sensor

The FDA has approved the first drug with a digital ingestion tracking system, according to a press release. Aripiprazole tablets with sensor (Abilify MyCite) features a sensor inside of the pill that sends a signal when the medication is ingested.

The sensor used in the smart pill initially received FDA marketing clearance in 2012.

The drug is approved to treat schizophrenia, manic and mixed episodes for patients with bipolar I disorder, and as an add-on for depression treatment.

The smart pill works by transmitting a message from the pill’s sensor to a patch, which then sends the information to a smartphone application, according to the FDA. In the app, patients can track medication adherence and give access to the data to caregivers and physicians.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA warns that label claims suggesting aripiprazole tablets with sensor may improve medication adherence have not been proven. Additionally, the smart pill should not be used for real-time tracking or during an emergency since detection can be delayed or may not happen, according to the release.

Aripiprazole tablets with sensor includes a Boxed Warning that elderly patients with dementia-related psychosis receiving antipsychotic drugs have an increased risk of death. The drug is currently not approved to treat these patients, according to the FDA.

The Boxed Warning also indicates that children, adolescents, and young adults may be at an increased risk of suicidal thoughts and behaviors. The FDA advises that patients should be monitored for this condition.

The most common side effects of aripiprazole include nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. Skin irritation may also occur due to the MyCite patch, according to the release.

Prior to patient use, the FDA urges healthcare providers to ensure that the patient is able to use the system.

“The approval of Abilify MyCite, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient’s illness management and personalized treatment plan. This information allows the opportunity for an open dialogue with the patient,” said John Kane, MD, SVP, Behavioral Health Services, Northwell Health. “Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug.”