FDA approves first digital pill

14 November, 2017, 19:22 | Author: Eloise Marshall
  • PavelKant  Shutterstock

The U.S. Food and Drug Administration said Tuesday it has approved Abilify MyCite (aripiprazole tablets) that has an ingestible sensor that records the medication was taken, the first drug in the U.S. with a digital ingestion tracking system. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA. Abilify contains a tracking device made by Proteus Digital Health, Reuters reports.

The system works by sending a message from the pill's sensor to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. "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".

FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge. It can also be used in the acute treatment of manic and mixed episodes associated with bipolar I disorder so it has the potential to do a whole lot of good.

Prior to patient use, the FDA urges healthcare providers to ensure that the patient is able to use the system.

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

Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd.

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement. 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.

"Patients can also permit their caregivers and physician to access the information through a web-based portal", the FDA noted - opening the possibility that others can track a patient's adherence (or lack thereof) to drug therapy. The drug is now not approved to treat these patients, according to the FDA.

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