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| Source: Proteus Digital Health |
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Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization. And this pill is focused on trying to prevent this noncompliance to medication, though in a narrow spectrum of medical disorders.
The approval marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem of non-compliance.
This 'digital pill' has a routine embedded medication, but also has in addition a sensor that can tell doctors whether, and when, patients take their medicine. The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery.
After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced after seven days. The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app. The app allows patients to add their mood and the hours they have rested, then transmits the information to a database that physicians and others who have patients’ permission can access.
It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.
Schizophrenia is a chronic, severe and disabling brain disorder. 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hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.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 behavior and a decreased need for sleep.
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 is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. It's safety and effectiveness has not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.
In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify 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.
Prior to 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.
The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.
Patients who agree to take the digital medication with a version of the antipsychotic Abilify can sign consent forms allowing their doctors and up to four other people, including family members, to receive electronic data showing the date and time pills are ingested.
A smartphone app will let them block recipients anytime they change their mind. Although voluntary, the technology is still likely to prompt questions about privacy and whether patients might feel pressure to take medication in a form their doctors can monitor.
Abilify is an arguably unusual choice for the first sensor-embedded medicine. It is prescribed to people with schizophrenia, bipolar disorder and, in conjunction with an antidepressant, major depressive disorder.
Many patients with these conditions do not take medication regularly, often with severe consequences. But symptoms of schizophrenia and related disorders can include paranoia and delusions, so some doctors and patients wonder how widely digital Abilify will be accepted.
Other companies are developing digital medication technologies, including another ingestible sensor and visual recognition technology capable of confirming whether a patient has placed a pill on the tongue and has swallowed it.
Not all will need regulatory clearance, and some are already being used or tested in patients with heart problems, stroke, H.I.V., diabetes and other conditions.
Because digital tools require effort, like using an app or wearing a patch, some experts said they might be most welcomed by older people who want help remembering to take pills and by people taking finite courses of medication, especially for illnesses like tuberculosis, in which nurses often observe patients taking medicine.
The technology could potentially be used to monitor whether post-surgical patients took too much opioid medication or clinical trial participants correctly took drugs being tested.
Another controversial use might be requiring digital medicine as a condition for parole or releasing patients committed to psychiatric facilities.
Abilify, a widely used drug, went off patent recently, and while other companies can sell the generic form, aripiprazole, Otsuka has exclusive rights to embed it with Proteus’s sensor.
Proteus has spent years bringing its sensor to commercial use, raising about $400 million from investors, including Novartis and Medtronic. Until now, the sensor could not be embedded in pills, but pharmacies could be commissioned to place it in a capsule along with another medication. In 2016, the encapsulated sensor started being used outside of clinical trials, but commercial use is still limited.
Nine health systems in six states have begun prescribing it with medications for conditions including hypertension and hepatitis C, where it has been found to improve adherence in patients with uncontrolled hypertension and others.
Other efforts:
Other efforts:
AiCure, a smartphone-based visual recognition system in which patients document taking medicine, has had success with tuberculosis patients treated by the Los Angeles County Health Department and is working with similar patients in Illinois. AiCure has shown promising results with other conditions, including in schizophrenia patients whose pill-taking would otherwise require direct observation.
A Florida company, etectRx, makes another ingestible sensor, the ID-Cap, which has been or is being tested with opioids, H.I.V. medication and other drugs. Made of magnesium and silver chloride, it is encapsulated with pills and avoids using a patch because it generates a low-power radio signal that can be picked up by an antenna that is in close proximity. The signal is detected by a reader worn around the neck, but etectRx aims to fit readers into watchbands or cellphone cases.
Concerns about privacy and coercion:
Seeking to address concerns about privacy and coercion, Otsuka officials contracted with several bioethicists. Among them, I. Glenn Cohen, a Harvard law professor, said safeguards adopted include allowing patients to instantly stop physicians and others from seeing some or all of their data.
Seeking to address concerns about privacy and coercion, Otsuka officials contracted with several bioethicists. Among them, I. Glenn Cohen, a Harvard law professor, said safeguards adopted include allowing patients to instantly stop physicians and others from seeing some or all of their data.
Asked whether it might be used in circumstances like probation or involuntary hospitalization, Otsuka officials said that was not their intention or expectation, partly because Abilify MyCite only works if patients want to use the patch and app.
How patients will view Abilify MyCite is unclear. The method might appeal to patients who want to prove their compliance, build trust with their psychiatrist, or who feel “paranoid about getting accused of not taking their medicine.”
References: FDA release; New York Times
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