Saturday, 25 November, 2017

FDA approves pill with digital ingestion tracking system

Theresa Hayes | 14 November, 2017, 20:04

The pill and its digital companions, now FDA-approved as Abilify MyCite, aren't likely to make a big difference to Otsuka's Abilify sales-certainly not immediately, given its plans for a limited initial launch.

"The approval of Abilify, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient's illness management and personalized treatment plan".

This first USA approval could bode well for other new products in the works, including sensor-embedded versions of generic blood pressure pill lisinopril and the standard diabetes drug metformin.

The ingestible sensor used in Abilify MyCite was first allowed on the market by the FDA in 2012. Some studies have shown that around 50% of chronic disease patients in developed countries do not take their medication as prescribed.

Always forget if you've taken your medication?

The pill is a variant of the drug Abilify from Otsuka Pharmaceutical Co Ltd. This is then transmitted to a mobile phone app, allowing patients to track their own compliance and share this data with caregivers and doctors.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers".

In combination though, the Abilify MyCite system was rejected by the FDA in April previous year due to concerns over the possible impact of "human factors" on safety.

The patch detects and records the time and date of when the pill was ingested as well as what is called "certain physiological data such as activity level". In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information. "If the MYCITE APP does not indicate that the ABILIFY MYCITE tablet was taken, do not repeat the dose".

The FDA says that the ability to track the consumption of prescribed medicines for mental illness may be useful "for some patients", although the ability of digital pills to improve patient compliance has not been proven.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.