The U.S. Food and Drug Administration approved a joint application by Proteus Digital Health and Otsuka Pharmaceutical for a medication monitoring tool for patients taking Otsuka’s drug Abilify. The drug is geared for people with schizophrenia, bipolar disorder and in some cases, depression.
Sensors, developed by Proteus Digital Health, are embedded in the pills and activated by stomach juices. The sensor transmits signals to a wearable with an electrode in the form of a skin patch. Data such as vital signs, body position, and verification of medication ingestion are wirelessly transmitted with the help of the wearable.
The FDA approval came with some caveats regarding the technology’s limitations, though. It noted that the ability of the sensors to track the patient’s 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 because detection may be delayed or may not occur,” the FDA news release said.
The approval for the pill monitoring platform came six months after Proteus and Otsuka had submitted a joint NDA for the second time after the regulator requested the companies to work out some issues in a complete response letter.
The ingestible sensor used in Abilify MyCite was cleared for marketing by the FDA in 2012. Abilify was approved ten years earlier.
The FDA approval for the joint submission clears the way for joint submissions by other pharma companies. Longterm, the Proteus platform could be used to tailor medicines more closely to reflect each of person’s medication-taking patterns and lifestyle choices.
Photo: ClarkandCompany, Getty Images
From drug developers all the way to providers, it’s key to find secure ways to access and use data to improve human health, all while protecting individuals’ privacy.
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