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