Digital Schizophrenia Pill With Sensor can Now Track Patients Taking the Medication

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Highlights:

• The approval of a digital pill by the USFDA can help patients, their doctors and family members track the date and time of pill ingestion.
• Abilify MyCite is the product name for aripiprazole tablets embedded with a sensor for use in patients who have schizophrenia, bipolar disorder, and depression.
• Schizophrenia is a brain disorder with symptoms including false beliefs, hallucinations, and unclear or confused thinking.

The first digital pill has been approved by the U.S. Food and Drug Administration (USFDA). The digital pill is embedded with an ingestible tracking sensor that tells the doctors whether, and when, patients take their medicine. The approved drug, Abilify MyCite contains aripiprazole which is an atypical antipsychotic that has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder. It is also used as an add-on treatment for depression in adults.

Abilify MyCite approval has been given to Otsuka Pharmaceutical Co., a Japanese based company that has manufactured the drug; the sensor technology and patch were created by Proteus Digital Health, a California company.

How does the Digital Monitoring System Work?

Abilify MyCite only works if the patients give consent to use the patch and app.
Once the pill is consumed, a message is sent from the embedded sensor to a wearable Band-Aid-like patch that must be worn on the left rib cage, which then transmits the date and time of pill ingestion and the activity level of the patient via Bluetooth to a smartphone application. The information is thus recorded on their phone. The patients can also sign consent forms that allow their doctors as well as four other people in their close circle like family members and caregivers to access this information through a web-based portal.

‘The approval of a digital schizophrenia pill by the USFDA can help patients, their doctors and family members track the date and time of pill ingestion in order to keep their condition under control.’

The patient can add more details to the application, like their mood and the number of hours they have rested.

"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 sensor contains ingredients found in foods like copper, magnesium and silicon and generates an electrical signal when it is splashed by stomach fluid, just like a potato battery, said Andrew Thompson, Proteus's president and chief executive.

Most common side effects reported by adults taking Abilify in clinical trials, were nausea, vomiting, constipation, dizziness, headache, uncontrollable limb and body movements (akathisia), anxiety, insomnia and restlessness.

Advantages and Disadvantages of Abilify MyCite

Abilify can address the expensive, longstanding problem that millions of patients do not take drugs as prescribed. It can help monitor medicine-taking, especially in patients who would are compliant to take the pills but forget to and definitely would not want the injection form as an alternative. It might also appeal to patients who want to prove their compliance, build trust with their psychiatrist, or who feel "paranoid (because of their condition) about getting accused of not taking their medicine."

While patients might feel their privacy getting checked, there is also an option for patients to instantly stop physicians and others from seeing some or all of their data.

On the other end, since Abilify MyCite is prescribed to people with schizophrenia, bipolar disorder and major depressive disorder who do not take their medications regularly, either because they do not like side effects, or they do not think they have an illness, or because they become paranoid and have delusions about the doctor or the doctor's intention, it might take some time to be accepted widely.

Also, Abilify MyCite cannot be used to track drug ingestion in "real-time" or during an emergency as the detection may be delayed or may not occur. The question that remains is whether the digital pill will be able to improve the patient's compliance.

Schizophrenia and Bipolar Disorder

Schizophrenia is a chronic, severe and disabling brain disorder with symptoms that start in adults younger than 30 years of age. People with schizophrenia hear voices, and believe that other people are reading their minds or controlling their thoughts. Bipolar disorder, also known as manic-depressive illness, is characterized by alternating periods of depression and high or irritable moods and energy, alternating activity levels and decreased the ability to carry out day-to-day tasks.

Reference:

1. FDA approves pill with sensor that digitally tracks if patients have ingested their medication - (https:www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm)

Source: Medindia

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