The newly approved pill, called Abilify MyCite, is a collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created the sensor.
The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomavh fluid, like a potato battery, said Andrew Thomson, Proteus’s president and chief executive.
After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replace after seven days, said Andrew Wright, Otsuka America’s vice president for digital medicine.
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.
Otsuka has not determined a price for Abilify MyCite, which will be rolled out next year, first to a limited number of health plans, Mr Wright said. The price, and whether digital pills improve adherence, will greatly affect how widely they are used.
Questions about the technology’s ability to increase compliance remain.
Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and NewYork-Presbyterain Hospital , said many psychiatrists would likely want to try digital Abilify, especially for patients who just experienced their first psychotic episode and are at risk of stopping medication after feeling better.
But he noted it has only been approved to track doses and has not yet been shown to improve adherence.
“Is it going to lead to people having fewer relapses, not having unnecessary hospital readmissions, being able to improve their vocational and social life?” he asked.
He added, “There’s an irony in it being given to people with mental disorders that can included delusions. It’s like a biomedical Big Brother.”
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, said Robert McQuade, Otsuka’s executive vice president and chief strategic officer.
“It’s not intended for all patients with schizophrenia, major depressive disorder and bipolar,” he added. “The physician has to be confident the patient can actually manage the system.”
Dr. McQuade said, “We don’t have any data currently to say it will improve adherence,” but will most likely study that after sales begin.
Proteus has spent years bringing its sensor to commercial use, raising about $400 million from investors, including Novartis and Medtronic, Mr. Thompson said.
In 2016, the encapsulated sensor started being used outside of clinical trials, but commercial use is still limited, Mr. Thompson said.
Nine health systems in six states have begun processing it with medications for conditions including hypertension and hepatitis C, the company said, adding that it has been found to improve adherence in patients with uncontrolled hyper tension and others.
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 or app.
How patients will view Abilify MyCite is unclear. Tommy, 50, of New York City, who takes Abilify for schizoaffective disorder, participated in a clinical trial for digital Abilify. Tommy. Who withheld his last name to protect his privacy, encountered minor issues, saying the patch was “a little bit unconfortable” and once gave him a rash.
William Jiang, 44, a writer in Manhattan with schizophrenia, took Abilify for 16 years. He said he steadfastly takes medication to prevent recurrenceof episodes of paranoia when “I was convinced everybody was trying to murder me.”
He said some noncompliant patients might take digital Abilify, especially to avoid Abilify injections recommended to patients who skip pills, but he was not keen on the pill for himself.
“I would not want an electrical signal coming out of my body strong enough so my doctor can read it,” Mr. Jiang said.
