Abilify MyCite, an atypical antipsychotic, is indicated in adults for the treatment of schizophrenia, for the treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as monotherapy, and as adjunctive therapy to lithium or valproate, and the adjunctive treatment of major depressive disorder.
Although now approved, Abilify MyCite will carry a warning in its labelling stating that the system has not been shown to improve patient compliance and that it "should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur".
Always forget if you've taken your medication? For one, compulsory court-ordered medical treatment of disorders runs into civil rights territory (though advocates say it's effective), and a sensor-equipped pill will let anyone with access to the data know exactly how often someone is taking their medication. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER".
While the rates at which patients deviate from their treatment regimens vary, estimates hold such actions cost the US healthcare system hundreds of billions of dollars each year.
In prescribing Abilify MyCite, physicians must make sure patients download the corresponding mobile application on their smartphones and are comfortable using it, since that is how they will ultimately view the information provided from the drug-device combo.
It was Otsuka and Proteus' second try at the FDA for the digital version of Abilify.
The companies said the sensor "activates when it reaches stomach fluids and communicates with the patch".
The patch detects and records the time and date of when the pill was ingested as well as what is called "certain physiological data such as activity level".
The Otsuka website notes, "It can take 30 minutes to 2 hours to detect ingestion of the tablet".
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a Monday statement. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.
Pills with digital tracking systems are said to be under consideration for other conditions.