"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", Dr. Mitchell Mathis, director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement. Abilify MyCite (aripiprazole tablets with sensor, Otsuka Pharmaceutical Co., Ltd.) has an ingestible sensor embedded in the pill that records that the medication was taken.
In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions. Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.
Abilify MyCite's future isn't certain, however. Other warnings include an increased risk of possible suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
Not necessarily. Abilify MyCite notes under its label that the product's ability to improve patient compliance with their treatment regimen has not been shown.
Abilify MyCite is not approved for treating patients with dementia-related psychosis. 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. Skin irritation at the site of the MyCite patch placement may occur in some patients. Once swallowed, the IEM sends a signal indicating the drug is in the patient's body to a wearable patch, which in turn passes the information along to a smartphone application.
Abilify MyCite hasn't been proven to improve patient compliance with taking medication on a prescribed schedule, the FDA stressed.
The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year.