Officials say the digital pill shouldn't be used to track drug ingestion in real-time or during an emergency, as detection may be delayed - or may not occur. The FDA said in a statement Monday that the digitally-enhanced medication "works by sending a message from the pill's sensor to a wearable patch". Abilify MyCite is approved for use for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with certain bipolar disorders and as an add-on treatment for depression in adults.
Patients can track their dosage on their smartphone and allow their doctors or caregivers to access the information through a website. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.
Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently.
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The most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body, anxiety, insomnia, and restlessness.
Abilify was first approved by the FDA in 2002 to Otsuka Pharmaceuticals for the treatment of schizophrenia.
"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. "This information allows the opportunity for an open dialogue with the patient", said John Kane, MD, SVP, Behavioral Health Services, Northwell Health.
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Aripiprazole tablets with sensor includes a Boxed Warning that elderly patients with dementia-related psychosis receiving antipsychotic drugs have an increased risk of death. The idea of a sensor that would send a signal to alert a caregiver, a healthcare professional, or a health plan has been much discussed at recent scientific meetings for diabetes clinicians and mental health professionals.
The system could be used to manage patients who have long, complex medical routines in the future.
In granting approval this time around, FDA makes note that Abilify MyCite's ability to improve patients' compliance with their treatment regimen hasn't yet been proven. "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".
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