FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

The US Food and Drug Administration (FDA) has approved Abilify MyCite (aripiprazole tablets), which contains an ingestible sensor that records whether or not the medication was taken. 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. This is the first drug in the US with a digital ingestion tracking system.

The pill’s sensor transmits information to a wearable patch, which then sends the information to a mobile application on patients’ smart phones. Patients can track the ingestion of the medication, and caregivers and clinicians can also access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, MD, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

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.

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. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults.

Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors.

Before a patient uses Abilify MyCite for the first time, clinicians must facilitate use of the medication, patch, and system to ensure the patient is able and willing to use it. The medication must also be dispensed with a patient Medication Guide with information about the drug’s uses and risks.

In clinical trials for Ability, first approved by the FDA in 2002 to treat schizophrenia, the most common side effects reported by adults were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

FDA approval of Abilify MyCite was granted to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

Reference