Digital Abilify pill secures first-of-its-kind FDA approval

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health

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.

GameStop PowerPass, Unlimited Used Games Program, Temporarily Suspended
GameStop announced a used game subscription service in late October that sounded nearly too good to be true. As a peace offering, affected customers will also get to pick out any pre-owned game for free.

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.

AWS Sells Chinese Cloud Assets Amid Tightening Regulations
Apple, the American company behind the iPhone juggernaut, has said it will establish a data center in China, for instance. The e-retailer added that it sold its physical assets of AWS to Sinnet in order to comply with the Chinese law.

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.

Vehicle Preview: 2019 Chevrolet Corvette ZR1
And looking across its product portfolio, the only cars that really do the trick right now are its high-performance autos. The engine is paired to a standard six-speed automatic transmission, with an optional eight-speed automatic transmission.

Latest News