FDA Approves 1st Digital Tracking Medicine
FDA has approved an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. The pill has a sensor embedded in it that records when the medication was taken. It is approved for treating schizophrenia, acute treatment of manic and mixed episodes associated with Bipolar I disorder and for use as an add-on treatment for depression in adults.
The product includes the Abilify MyCite, the MyCite Patch (a wearable sensor developed by Proteus), the MyCite App, which is a smartphone application to display patient information for the patient and Web-based portals for healthcare providers and caregivers that display a drug ingestion summary over time. The embedded sensor is the size of a grain of sand, and is made up of food ingredients, according to Otsuka. It activates when in contact with stomach fluid and signals the wearable patch.
The patient in collaboration with a physician decides whether the product may help them manage their treatment, the company says. “The system has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialog with their healthcare team,” it says. “The system is intended to integrate into individuals’ lives, and individuals indicate through the app which member(s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest.” At any time, patients can decide to discontinue sharing some information from the system, or opt out of the program altogether.
Only the app functions related to tracking drug ingestion have been approved by FDA. “It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown,” an agency release says. “Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or may not occur.”
Several medical ethicists wonder about a “big brother” effect by others being able to monitor drug ingestion and other self-reported data being captured with this and other similar products likely to come to market down the road. Peter Kramer, a psychiatrist and author of “Listening to Prozac,” raised concerns about “packaging a medication with a tattletale,” according to the New York Times. While ethical for “a fully competent patient who wants to lash him or herself to the mast,” he said, “‘digital drug’ sounds like a potentially coercive tool.”
Scripps Translational Science Institute director Eric Topol told the NY Times that insurers might eventually give patients incentives (discounts on copayments) to use them, adding that ethical issues could arise if the technology was “so much incentivized that it’s almost like coercion.” Another controversial use might be requiring digital medicine as a condition for parole or releasing those committed to psychiatric institutions, the paper said.
Abilify MyCite is approved with a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. It also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants, indications which are not approved. In clinical trials, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia, and restlessness, according to FDA.