First "Digital Pill" Gains FDA Approval

After 2 years of regulatory hurdles, the US Food and Drug Administration has approved a new tool for patients with mental illnesses taking aripiprazole tablets (Abilify)—a digital sensor that reports when patients have taken their medication (Abilify MyCite).

For the new digital pill, a sensor that is approximately the size of a grain of sand is embedded into the aripiprazole tablet, according to Proteus Digital, the company that develops the sensor. Upon reaching the fluids in the stomach, the sensor begins to report that it has been ingested to a patch worn on the skin, which is synced to an application on a smart phone. In addition to reporting that it has been ingested, the sensor also records drug activity data.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, and was subsequently rejected, with a request from the FDA for more information on the digital drug. A resubmission of the new drug application was accepted by the agency in May 2017.

Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia, with other indications granted 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 agent and sensor are now 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.

“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 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 levels 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 published 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.