The US Drug and Drug Administration (FDA) on Monday approved for the first time a digital antidepressant drug equipped with a surveillance sensor for its delivery.
Many patients do not take the prescribed medication, making it difficult to monitor their condition. The approved drug may change this uncertainty, which makes it difficult for medical staff to follow the patient’s medication routine.
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The drug, Abilify MyCite (aripiprazole tablets with sensor) is manufactured by the Japanese Otsuka Pharmaceutical and approved for the treatment of schizophrenia, bipolar disorder, and an antidepressant supplement in adults.
The technology has been incorporated into the pill, developed by American Proteus for years.
The system works by sending a message from the grain-size pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
The sensor is activated when it reaches stomach fluids and communicates with the patch. In addition, the sensor does not need a battery and is activated as soon as it gets wet from stomach juices, on the basis of a chemical reaction that produces electricity.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”
Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.
Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.
Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis.
MyCite also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants.
The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.
The most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.
Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.
