Dr. Mitchell Mathis of the FDA says officials support "use of new technology in prescription drugs and is committed to working with companies to understand how the new technology might benefit patients and prescribers". The medication is indicated for the treatment of adults with schizophrenia, acute treatment of adults with manic and mixed episodes in bipolar I disorder, and as an add-on treatment for adults with depression.
The system works by sending messages from a pill sensor to a usable patch material, which then transmits the information to the mobile app so that patients can track drug consumption on their smart mobile phone.
The FDA noted that Abilify MyCite has not demonstrated an ability to improve patient compliance; therefore it should not be used to track medication ingestion in real-time or during an emergency, as detection may be delayed or may not occur.
Providing they sign a consent form, patients can allow up to four other people, including their doctors, caregivers, and family members, to access the data via a web-based portal.
Abilify MyCite is not approved for patients with dementia-related psychosis; it has a Boxed Warning that taking this medication puts patients with dementia-related psychosis at an increased risk of death. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out.
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.
Abilify MyCite's future isn't certain, however. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.
The sensor in the pill digitally tracks whether or not patients have ingested their medication.
Abilify MyCite is not approved for treating patients with dementia-related psychosis.
The FDA approved Abilify in 2002 to treat schizophrenia, which affects about one percent of the U.S. population.
Ablify MyCite is a version of aripiprazole tablets that have a sensor inside. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.