The US Food and Drug Administration (FDA) has approved Abilify MyCite (aripiprazole tablets), which contains an ingestible sensor that records whether or not the medication was taken. Abilify MyCite must be dispensed with a patient medication guide that describes important information about the drug's uses and risks.
According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression. Abilify MyCite is not approved to treat patients with dementia-related psychosis.
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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Technology has been a vital tool for manufacturers and healthcare providers looking to improve patient adherence.
The system in the drug offers an objective way to measure whether patients have taken their pills on schedule, which opens up new ways to monitor treatment compliance that can be applied in other therapeutic cases.
"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", said Mitchell Mathis of the FDA's Center for Drug Evaluation and Research. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.
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The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. A resubmission of the new drug application was accepted by the agency in May 2017.
And Otsuka is aware that Abilify MyCite is a more complicated product than the usual pill, and it'll be more hard to market, too. The Japanese pharma reported Abilify sales of ¥53.6 billion (about $479 million) for the first nine months of 2017, down 30% from the same period in 2016. Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal. At first techno-blush, concerns about Big Brother tapping one's body fall to the wayside; patients can voluntarily give access to the information gathered by the sensor to their doctor and designated family members or caretakers.
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