A Digital Drug that Tracks Your Daily Pills -Abilify MyCite,
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system- the Abilify MyCite (aripiprazole tablets with sensor).
It has an ingestible sensor embedded in the pill that records that the medication was taken.
The smart pill’s manufacturers – Otsuka (which makes Abilify) and Proteus (the IEM developer) – bill their innovation as “the first digital medicine system”, which they say will make it easier for caregivers to objectively monitor patients’ adherence to medication regimens.
Abilify MyCite is fitted with a tiny ingestible sensor that communicates with a patch worn by the patient — the patch then transmits medication data to a smartphone app which the patient can voluntarily upload to a database for their doctor and other authorized persons to see. Abilify is a drug that treats schizophrenia, bipolar disorder, and is an add-on treatment for depression.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and young adults. Those on antidepressant therapy should be monitored closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.“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,” said Mitchell Mathis of the FDA’s Center for Drug Evaluation and Research.
About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.
In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.
“The approval of ABILIFY MY CITY, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, 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,” said John Kane, MD, SVP, Behavioral Health Services, Northwell Health and Chair, Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “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.”
Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd., remarked, “This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies. We remain committed to making a difference for individual patients and their care team by helping address the challenge of objectively measuring medication ingestion. Our rollout of the Abilify Mycite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients.”
Andrew Thompson, president and chief executive officer of Proteus Digital Health said, “The time is right for the category of Digital Medicines to be available to appropriate patients with the serious mental illness. Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smartphones, as they go about their daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”
Otsuka Pharmaceutical, which is a unit of Tokyo-based Otsuka Holdings Co., plans to start the program with just a handful of health systems and gather evidence on the drug’s effects on adherence.
This initial approval could open the doors for other medication-technology combos in the coming years. Maybe various medications will become more “chatty” in the near future such as tablets yelling to you “it’s time, it’s time”, warning “now, don’t take me with that other pill, I don’t get along with that other pill”, saying “no, that’s not where I go, don’t put me there.”
Embedding digital technology in medications could also eventually provide ways for doctors to monitor others things within the human body. In other words, in the future, pills may not only have “mouths” but potential “eyes”, “ears”, and even “noses.”
