FDA Approves Pill With Sensor Abilify MyCite; Otsuka Stock Up

Allan Goodman
November 16, 2017

Abilify MyCite is an antipsychotic pill that uses a sensor-based technology to help patients, as well as doctors, keep track of ingestion, a message to a wearable sensor patch where the information is then forwarded to a smartphone app.

Big news for the health industry: U.S. regulators have approved a pill that can be digitally tracked through the body using an ingestible sensor and a patch worn by patients.

The FDA has approved the first smart pill for use in the United States.

"The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness", said Andrew Thompson, president and chief executive of Proteus Digital Health. "You would think that, whether in psychiatry or general medicine, drugs for nearly any other condition would be a better place to start than a drug for schizophrenia", says Paul Appelbaum, director of Columbia University's psychiatry department in an interview with the New York Times.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence". "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients". This signal will be picked up by a patch on the patient's left rib cage, which will then notify the monitoring personnel via the accompanying app.

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.

Doctors now have an easier - but controversial - way to know if their patients have taken their medication.

The technology carries risks for patient privacy too if there are breaches of medical data or unauthorised use as a surveillance tool, according to James Giordano, a professor of neurology at Georgetown University Medical Centre.

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Abilify MyCite's labeling notes that the ability of the product to improve patients' 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", the statement said, "because detection may be delayed or may not occur".

However, the makers behind it, Japanese company Otsuka Pharmaceutical, developed a new version called Abilify MyCite that comes with a tiny ingestible sensor inside each pill.

On Monday, the FDA said the digital drug pill might be useful for some patients. The drug Abilify (with or without the digital sensor) can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements. Safety and effectiveness has not been established in children.

The system can also "help remind people with schizophrenia if they forgot to take medications", Birnbaum said. "And those things would not really be addressed by a pill with a sensor", she adds. It's also been approved as a supplemental treatment for adult depression. "For those reasons, a device like this could indeed be very helpful, and I think it should be applauded", Malaspina says.

"However, we will need to be convinced that the overall therapeutic and costs benefits of the medication tracker make it worthwhile", she said. "This could be an incredible intervention for individuals and their families that would allow them to check in every day or two, without having to go to a higher level of care".

Many people recover from schizophrenia, but can experience relapses if it's not managed.

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