By: David Hamel, Fellow Scientist Cato Research Canada
The FDA approval of Abilify MyCite (aripiprazole tablets with sensor; by Otsuka) on 13 November 2017 for the treatment of 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 could mark a new era in patients’ medication adherence technology. The new product combines the antipsychotic aripiprazole in its tablet formulation and a drug ingestion tracking system comprised of an Ingestible Event Marker (IEM) sensor, a wearable patch (MyCite Patch), a mobile application, and a web-based portal, that identifies and relay drug ingestion events to the patient’s smartphone. In addition, the patient can permit their caregivers and physician to access the information through the web-based portal. This is the first drug with a digital tracking system approved in the U.S. Although, Abilify MyCite was not designed to improve patient compliance or modify drug dosage, this technology could eventually be paving the way for a new standard in medication adherence and chronic disease management.
The FDA approved aripiprazole in 2002 for the treatment of schizophrenia. Since then, the drug was approved for bipolar I disorder (September 2004) and as an adjunctive treatment of major depressive disorder in adults (November 2007). The FDA approved the ingestible sensor for marketing in 2012. The true innovation of Abilify MyCite resides in its integrated tracking system. At the core of this technology lies a 1-mm sized sensor activated by the reaction between two of its constituents, magnesium and cuprous chloride, in the presence of gastric fluid, which power the sensor. The signal is detected by a wearable sensor (MyCite Patch) located on the patient’s torso, which in turn relays the ingestion event to an application on the patient’s mobile device. In practice, the ingestion events can be detected between 30 minutes and 2 hours after each dose. The patch, which can be worn while showering, swimming or exercising, should be changed at least every week, and be located within 9-foot of the paired smartphone to properly communicate the information. Preclinical studies assessed the safety of ingesting the Event Marker. The safety profile supports the use of the technology in the treatment of chronic diseases.
While the approval is an excellent news for individuals suffering from mental disorders, patients affected by other chronic diseases could in theory benefit from the deployment of this technology in other therapeutics areas, such as AIDS, asthma, tuberculosis, hypertension and organ transplant, in which medication compliance is also critical. While the stated objective supporting the marketing of the Ingestible Event Marker is to provide better information to healthcare providers, the companies remain in a grey area between simple information and the objective quantification of adherence. Therefore, further studies designed to evaluate the impact of Abilify MyCite on compliance would be required.
We should also consider the impact of system defects and improper use on the treatment. Whether a faulty detection or software glitch, the risk of inadequately capturing the ingestion events would prevent healthcare providers from adequately determining if patients are taking their medication. Alternatively, this improper tracking could also lead to patients taking more than the prescribed dose. The Prescribing Information indicates the possibility that the ingestion of the tablet may not be detected. To avoid this, patients should receive adequate training on how to position and pair the patch with the application. Proteus Digital Health, the device developer and manufacturer of the system, reported a detection accuracy of 99.1% during clinical trials. They attributed faulty detections to a combination of stomach environment and receiver-sensor orientation.
As with many new technologies, concerns over privacy can be raised. For example, we can consider the security of software and servers necessary to transmit the relevant information to healthcare providers. Will they be sufficiently secured and properly maintained? Who will have access to the information and who will make the choice to grant access to certain individuals or not? What about patients with severe cognitive impairment unable to permit their caregivers and physician to access their information? We can also contemplate a future where insurers could require a “proof of ingestion” before reimbursing the treatment.
Abilify MyCite clinical studies demonstrated that the device was safe and that this technology could provide reliable and accurate information with manageable risks to patients. This new combination product could provide physician valuable insight into their patients’ behavior and ultimately guide the discussion on how to improve their treatment.
For more information about Abilify MyCite visit:
FDA New Release (November 13, 2017): https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm?utm_campaign=FDA%20approves%20pill%20with%20sensor%20that%20digitally%20tracks%20if%20patients%20have%20ingested%20their%20medication&utm_medium=email&utm_source=Eloqua
Otsuka America Pharmaceutical: https://www.otsuka-us.com/discover/articles-1075
 FDA Approval Enclosure documentation
 Proteus Digital Health, press release 30 July 2012, online at http://www.proteus.com/press-releases/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor-2/
 Hafezi H et al., An Ingestible Sensor for Measuring Medication Adherence IEEE Transactions on Biomedical Engineering, vol 62, NO. 1, January 2015
 Sabaté E, editor. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003
 Hafezi H et al., An Ingestible Sensor for Measuring Medication Adherence IEEE Transactions on Biomedical Engineering, vol 62, NO. 1, January 2015.