Proving the Business Case for the Internet of Things

Pill contains sensor to show physicians it has been taken

Steve Rogerson
November 21, 2017



The US Food & Drug Administration (FDA) has approved the first drug in the USA with a digital ingestion tracking system. The Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.
 
The product has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
 
The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical. The sensor technology and patch are made by Proteus Digital Health.
 
“The approval of Abilify MyCite, 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 personalised treatment plan,” said John Kane from the Donald & Barbara Zucker School of Medicine. “This information allows the opportunity for an open dialogue with the patient. 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.”
 
The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile app so patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
 
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the division of psychiatry products for the FDA. “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.”
 
Japanese company Otsuka’s approach for this treatment is novel for a pharmaceutical company. As such, the launch of Abilify MyCite 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. 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 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.
 
“This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies,” said Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical. “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, added: “The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness. Consumers already manage important tasks like banking, shopping and communicating with friends and family by using their smart phones 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.”
 
Schizophrenia is a chronic, severe and disabling brain disorder. About one per cent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.
 
Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behaviour, and a decreased need for sleep.
 
Abilify MyCite’s prescribing information (labelling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. It should not be used to track drug ingestion in real time or during an emergency because detection may be delayed or may not occur.
 
Abilify MyCite contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. It has not been approved to treat patients with dementia-related psychosis.
 
The boxed warning also warns about an increased risk of suicidal thinking and behaviour in children, adolescents and young adults taking antidepressants. The safety and effectiveness of have not been established in paediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviour.
 
Abilify MyCite must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks.
 
In the clinical trials for Abilify, the most common side effects reported by adults were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.
 
Before initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.
 
Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.