FDA approved the first pill to incorporate digital tracking capability.
Otsuka Pharmaceutical Co Ltd. recently received FDA approval for Abilify MyCite, a version of Abilify (aripiprazole), its drug for the treatment of schizophrenia, bipolar disorder and depression that is formulated as a tablet containing a digital tracking device that indicates whether a patient has taken his/her medication properly.
The pill is the first to be approved by FDA with an embedded sensor, which was developed by Proteus Digital Health. Doctors can determine if patients are swallowing the pills at the proper time, providing a new mechanism for improving medication adherence.
Patients prescribed this medication wear a patch that receives signals from the sensors in the pills and then sends the data to an application on a smartphone. The sensors are tiny – the size of a grain of salt – and are activated when wetted by fluids in the stomach through completion of a circuit between coatings of copper and magnesium on either side of the pill, generating an electric charge. The sensor was first approved by FDA in 2012.
Although there is no proof that digital tracking leads to improved compliance, for some patients with mental illnesses, being able to track the ingestion of mediations could useful, according to FDA. “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.
Future applications are envisioned for the digital technology, including helping patients manage chronic diseases such as diabetes and heart diseases, where medication adherence is often poor.