Otsuka Partners to Bring Smart Pill to Market
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Otsuka America Pharmaceutical, which received US Food and Drug Administration (FDA) approval for a so-called “smart pill” in 2017, has formed a partnership to support the marketing in the US of the drug–device combination product of Abilify (aripiprazole) embedded with an ingestible sensor in a single tablet, the first such product approved by the FDA.

Otsuka had partnered with Proteus Digital Health, a Redwood City, California-based developer of digital medicine systems, to develop the sensor embedded in the tablet, which measures patient medication-taking patterns as well as select physiological data and self-reported behavioral information. In 2017, the FDA approved Abilify Mycite (aripiprazole tablets with sensor), a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an ingestible event marker (IEM) sensor. The Abilify Mycites includes: Abilify Mycite; the Mycite patch, a wearable sensor; the Mycite app, a smartphone application; and Mycite Dashboard, a web-based portal for healthcare providers and caregivers.

Abilify Mycite was approved by FDA in November 2017 as the first drug-device combination product intended to track the ingestion of a medicine. Abilify Mycite (aripiprazole tablets with sensor) is approved for treating adults with schizophrenia, bipolar disorder, and major depressive disorder.

Under a new agreement, Otsuka has agreed to facilitate access to its Abilify Mycite System to certain regional provider networks contracted through Magellan Health, a Scottsdale, Arizona-based healthcare company. The collaboration agreement creates the opportunity for physicians and adult patients to gather experience in a real-world setting with the Abilify Mycite System.

Otsuka says that the initial rollout of the Abilify Mycite System is purposeful and allows patients in select regional provider networks contracted through Magellan Health to receive the opportunity to opt in to this program. “By focusing on fewer individuals using the Abilify Mycite System System at first, Otsuka and Magellan Health will be better able to understand how it fits within the daily lives of those with serious mental illness and their caregivers, how doctors will integrate it into their daily practice, and how patients may benefit from more information about their care,” said Otsuka in an August 30, 2018 company release. “As a result, Otsuka will be able to consider ways to improve the Abilify Mycite System to enhance the experience and better serve prospective patients, their caregivers, and physicians in the future.”

Abilify Mycite System consists of the IEM sensor, which is approximately 1 mm and is made up of ingredients found in food. The IEM sensor activates when in contact with stomach fluid and communicates to a wearable sensor called the Mycite Patch. The Mycite Patch detects and records the date and time of the ingestion of the tablet, as well as certain physiological data such as activity level, and communicates this and the tablet ingestion data to the Mycite App on a compatible mobile device. The Mycite App allows patients to review their objective medication ingestion and daily activity level as well as enter their mood and rest if they wish to do so. Web-based dashboards are provided to healthcare providers and caregivers. These dashboards give the healthcare provider the ability to display the individual’s drug ingestion patterns over time.

Source: Otsuka Pharmaceutical

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