United States regulators approve first digital pill to track patients

15 November, 2017, 02:03 | Author: Carmen Reese
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Abilify MyCite is the first pill of its kind to get FDA approval, though, paving the way for a new kind of drug that may aid in patient compliance.

The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify - long used to treat schizophrenia and bipolar disorder - with a sensor tracking system first approved in 2012.

According to Higuchi, the Abilify MyCite will be rolled out in phases to allow them to gather and respond to feedback provided by patients and health care providers. This sensor is obviously ingested when the patient takes their medication; it provides data to a related patch the patient wears while taking the meds.

Of the many hurdles drugmakers face - mastering complex science, navigating regulations, crafting successful marketing campaigns - patient adherence remains one of the most hard to clear.

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"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", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA. Each MyCite pill comes with a tiny ingestible sensor that communicates with a wearable patch placed on the patient's skin, which itself communicates with a smartphone app. Some use email and text reminders, while others have turned to devices such as smart pill bottles that keep track of how much medication a patient has gone through.

Abilify MyCite's future isn't certain, however.

"Dr. Shrank sees the potential in the new sensor technology to improve public health but also cautioned that improper usage "...could foster more mistrust instead of trust". Data from the patch sends the information to a mobile app, which can be monitored by patients, caregivers, and physicians via web portal.

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year. "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".

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