A digital pill embedded with a sensor that can tell doctors whether patients have taken their medicine has been approved in the US.
The Food and Drug Administration (FDA) said in a statement that the digitally enhanced medication – called Abilify MyCite – “is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults”.
The original Abilify pill, developed by Japanese drugmaker Otsuka Pharmaceutical, was first approved by the FDA in 2002 to treat schizophrenia, while the ingestible sensor technology, created by California-based Proteus Digital Health, was approved for marketing in 2012.
The FDA granted the approval of the digital drug Abilify MyCite to Otsuka Pharmaceutical.
Dr Mitchell Mathis, of the FDA, said: “Being able to track ingestion of medications prescribed for illness may be useful for some patients.
“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.”
The system works by sending a message from the pill’s sensor to a wearable patch. The sensor activates when it reaches stomach fluids.
The patch transmits the information to a mobile application where patients can track their dosage on their smartphone and allow their doctors or caregivers to access the information through a website.
The FDA said that while the system can track doses, it hasn’t been shown to improve patient compliance.
“Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency,” the statement said, “because detection may be delayed or may not occur.”
The invention is intended for patients with mental illnesses who don’t always take their medication or may be forgetful, which could potentially put the success of their treatment in jeopardy.
In a statement issued last May – at the time the FDA accepted submission of product for review – the companies said “with the patient’s consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient’s needs”.