FIRST FDA APPROVED DIGITAL MEDICINE – BRIEF NOTE
Rajesh S Vagh
PharmaTutor Edu Labs,
Surat, Gujarat, India
Last year in November, FDA had approved first DIGITAL MEDICINE, ABILIFY MYCITE which is a drug-device combination product comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. In simple word, it is an aripiprazole tablet with sensor. It is indicated in adults for the treatment of schizophrenia, bipolar I disorder, acute treatment of manic and mixed episodes as monotherapy and as adjunct to lithium or valproate, maintenance treatment as monotherapy and as adjunct to lithium or valproate and adjunctive treatment of major depressive disorder.
Otsuka’s aripiprazole tablet is embedded at the point of manufacture with an IEM sensor; The IEM sensor activates when in contact with stomach fluid and communicates to a wearable sensor, called the MYCITE ® Patch which detects and records the date and time of the ingestion of the tablet, as well as certain physiological data such as activity level. The ABILIFY MYCITE System is intended to track if medicine has been taken. It can take 30 minutes to 2 hours to detect ingestion of the tablet. The information collected in the Patch is communicated to the MYCITE ® APP, a smartphone application, on a compatible mobile device. The MYCITE APP allows the patient to review their objective medication ingestion data with their doctor. Activity level can also be recorded by the app, as well as self-reported mood and quality of rest. Only functions of the app related to tracking drug ingestion have been approved by the FDA. The individual can also choose through the MYCITE APP that which member(s) of their care team or family can access their information, and can grant or withdraw permission at any time. This system also contains secure web-based dashboards which give the healthcare provider or family member access to medication ingestion patterns over time.
Otsuka's approach for this first-of-its-kind treatment is novel for a pharmaceutical company. As such, the launch of the ABILIFY MYCITE system will be conducted in close collaboration with only a select number of health plans and providers, who will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder who may benefit from this new digital medicine system. This limited rollout is purposeful, as having fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients' experiences. Through ongoing feedback from those using the system every day, Otsuka will further enhance the experience for all prospective users of the ABILIFY MYCITE system. This initial limited rollout will be a crucial step in determining Otsuka's broader go-to-market plan.
There is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient's illness management and personalized treatment plan. This information allows the opportunity for an open dialogue with the patient.
How digital medicine can impact us
No doubt to say that we are living in digital era and we should not surprise with digital medicines concept. Actually, this was expected and it is need of the time. Imagine, if we take any pill and we and our doctors can actually see how it is impacting our body, how our body reacting to it and we can track level of effectiveness. We shall get ideas on pharmacokinetics and pharmacodynamics of medicines and physicians can actually plan pharmacotherapy from this precious data. This will make easier for doctors to make decisions on therapy.
The reports generated with different patients, we can able to get drug insights and it will make pharmacovigilance much easier, faster and accurate.
In developed countries, it will be easier for doctors to communicate with patients in case of any emergency require while patient is not in hospital. Care taker or relatives can understand need of therapy and its impact easily.
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