FDA Approves Sensor-Equipped Schizophrenia Pill
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Dr. Mitchell Mathis, M.D., director of the Division of Psychiatry Products in FDA's Center for Drug Evaluation and Research.
FDA announced it has approved Abilify MyCite, a pill with a sensor that digitally tracks whether a patients has ingested the medication, on Nov. 13. The agency said it the first drug in the United States with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) contains an ingestible sensor that records that the medication was taken. 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.
The agency said the system works by sending a message from the sensor to a wearable patch, which transmits the information to a mobile app so patients can track the ingestion of the medication on their smart phones. Patients can allow caregivers and physicians to access the information through an online portal.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Dr. Mitchell Mathis, M.D., director of the Division of Psychiatry Products in 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."
Abilify MyCite's labeling notes that the ability of the product to improve patients' compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in real time or during an emergency because detection may be delayed or may not occur, FDA stated.
Abilify was first approved by FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. FDA said in the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia, and restlessness.
FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.