U.S. regulators have approved the first pill that contains a digital tracking sensor to alert doctors and caregivers as to whether a patient is taking a medication as scheduled. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults. They can choose to stop sharing the data at any time, and can track the information themselves through a smartphone app.
The information can also be sent to the prescribing doctor, if the patient consents to this. The drug Abilify was first approved by the FDA in 2002 to treat schizophrenia, and the ingestible sensor, made by Proteus Digital health, was approved for marketing in 2012. The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times.
The companies said the Proteus Ingestible sensor "activates when it reaches stomach fluids and communicates with the patch".
In a statement on Monday, the FDA said that the digitally-enhanced drug "works by sending a message from the pill's sensor to a wearable patch".
The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, and was subsequently rejected, with a request from the FDA for more information on the digital drug. Estimates suggest that 50% of patients with chronic conditions do not take their medications, costing the United States healthcare system upwards of $100 billion in avoidable costs. Additionally, the smart pill should not be used for real-time tracking or during an emergency since detection can be delayed or may not happen, according to the release.
Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
"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", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA. Other warnings include an increased risk of possible suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.