FDA Approves First Pill With Digital Tracking System

The US Food and Drug Administration has approved aripiprazole tablets with a sensor to digitally track whether patients have taken their medication (Abilify MyCite). The agent and sensor is approved for schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults.

Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia, with subsequent indications for other mental illnesses. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA. The sensor in Abilify MyCite syncs with a smart phone and sends an alert when the medication is ingested via a patch worn on the skin.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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 application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug. A resubmission of the new drug application was accepted by the agency in May 2017. The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole is marketed by Otsuka Pharmaceutical.

The sensor embedded into the tablet is approximately the size of a grain of sand, according to Proteus. The sensor is activated upon reaching the fluids in the stomach, where it begins to report that is has been ingested. Additionally, the sensor also records pharmacokinetic and pharmacodynamic data on activity level.

The FDA advised that healthcare professionals should show patients how to use the drug, patch, and app before prescribing the medication. Data from the tracker can be kept private for the patient alone to see, with the option to share data with healthcare professionals or other individuals, if desired. On the app, patients can also share information on measures of rest and mood.

The ability to track ingestion of the medication is meant to cut back on medical waste while improving adherence, although data to support this are lacking for Abilify MyCite, according to the FDA. Estimates suggest that 50% of patients with chronic conditions do not take their medications, costing the US healthcare system upwards of $100 billion in avoidable costs. Additionally, according to findings publish in the Journal of Clinical Psychiatry, patients with schizophrenia are particularly vulnerable to non-adherence.

In addition to lacking data supporting improvements in adherence, the FDA also noted that the patch and sensor should not be used in an emergency to ensure treatment has been taken. In general, communication between the pill, patch, and app are delayed, and data are not available in "real-time," according to the FDA.

Keeping with the longstanding label for aripiprazole, Abilify MyCite was also approved with a Boxed Warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.