The U.S.
Food and Drug Administration today approved the first drug in the U.S. with a
digital ingestion tracking system, to track whether you have ingested it or
not. The drug-device combination is Abilify MyCite, it comes with an
embedded Ingestible Event Marker (IEM)
sensor, and is manufactured by Japan-based Otsuka Pharmaceutical.
The ABILIFY MYCITE System includes: ABILIFY MYCITE, the
MYCITE® Patch (wearable sensor); the MYCITE APP (a smartphone
application); and web-based portals for healthcare providers and caregivers.
Abilify is
the brand name for Aripiprazole, an antipsychotic used to treat schizophrenia,
bipolar disorder and as an add-on treatment for depression in adults.
The sensor
is the size of grain of sand and is made from ingredients found in food. As
soon as the tablet is ingested,the sensor is activated by coming in contact
with stomach acid. It communicates with the wearable sensor, called the MYCITE
Patch which detects
and records the date and time the pill is ingested.
The Mycite
Patch in turn communicates the data with the MYCITE APP on a compatible
mobile device.
The patient’s
healthcare providers and caregivers also can view the data and record the
patterns of drug ingestion by the patient via Web-based dashboards. With
patient consent, selected members of the family and care team can also access
this information.
The system
targets the major problem of ‘nonadherence’ to medications in US, common with
people suffering from hypertension and diabetes.
“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 in a
press release. “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.”
The prize of
the medication will be finalized in 2018, when the initial rollout of drugs begins.
Decisions
for development of other digital medication is under consideration, especially for diabetes and hypertension.
FDA News Release
Proteus Press Release
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