November 13, 2017
Authored and Edited by Yieyie Yang, Ph.D.; Susan Y. Tull
On November 13, 2017, the FDA approved the first prescription drug in the U.S. with a digital ingestion tracking system, ABILIFY MYCITE® (aripiprazole tablets with sensor). This digital medicine is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults. This digital medicine system allows patients to track the ingestion of their medications on their smartphone and allow their physicians to obtain the information through the web-based portal
The ABILIFY MYCITE system is comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor to track drug ingestion, a MYCITE Patch (wearable sensor) that detects the signal from the IEM sensor after ingestion and transmits data to a smartphone, a MYCITE App that is used with a compatible smartphone to display information for the patient, and a web-based portal for healthcare professionals and caregivers.
The IEM sensor is only 1mm in size and made of silicon, copper, and magnesium. Upon contact with gastric acid, magnesium and cuprous chloride within the IEM react to activate and power the device to transmit signal to the MYCITE Patch on the surface of the patient’s body that further transmits the signal to the smartphone, enabling tracking. According to the package insert, most ingestions will be detected within 30 minutes.
The FDA’s approval of this drug-device combination product demonstrates its support of the development and use of new technology in prescription drugs. One can envision other applications of this type of technology to track ingestion of other medications for patients with compliance issues or to track medications for other high-risk diseases that require close adherence. The technology also could potentially be used to monitor drug abuse or clinical trial subjects’ compliance. This first FDA approval may incentivize more joint ventures between pharmaceutical companies and medical device, semiconductor, and software companies for digital medicine design and development.
IP right protection of digital medicine could also become another new area that requires creative collaborations among patent attorneys and joint venture companies. For instance, patents could be filed to cover pill formulations, ingestible sensors, methods of tracking ingestion and treatment, and apps to be used with the pills with improved functionality. For this type of combination products, patent transactions could potentially become important as well.
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