The United States Food and Drug Administration (FDA) has granted the first approval of a digital medicine system ABILIFY MYCITE or aripiprazole tablets with a sensor. Otsuka's oral aripiprazole tablets, in this case, will be embedded with an Ingestible Event Marker (IEM) sensor.
The ABILIFY MYCITE Patch includes a wearable sensor developed by PROTEUS, the MYCITE APP which can be used with a compatible smartphone to display information for the patient and web-based portals helping the healthcare providers and caregivers, presenting a summary of aripiprazole ingestion over time, stated FDA.
Proteus Ingestible sensor activates when it reaches stomach fluids and communicates with the patch.
Aripiprazole, sold under the brand name Abilify, is primarily used in the treatment of schizophrenia and bipolar disorder. It is also used in the treatment of major depressive disorders and irritability linked to autism. Only functions of the app related to tracking drug ingestion have been approved by the FDA.
ABILIFY MYCITE, however, has not been approved for the treatment of patients suffering from dementia-related psychosis or in case of pediatric patients.
The drug ABILIFY MYCITE was developed by Otsuka Pharmaceuticals Co.Ltd and was approved by the FDA in 2002 in order to treat schizophrenia. The ingestible sensor created by Proteus Digital health was given a green signal for marketing in 2012.
"Our rollout of the ABILIFY MYCITE system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients" said Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical.
President and chief executive officer of Proteus Digital Health, Andrew Thompson adds:"The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness."
FDA has further stated that the ability of the product to improve patient compliance with their treatment routine has not been shown. Moreover, FDA commented that ABILIFY MYCITE should not be used in 'real time' or during an emergency as the detection might take longer time or might not occur at all.
While speaking of the product's authenticity and privacy, the FDA in its statement said that the wearable patch that comes with the medication delivers the information to the mobile, following which the patient can track the ingestion of the medication.