The FDA approved a first drug–device product that uses a digital chip to monitor ingestion. This tracking technology could help address the costly problem of poor drug adherence in both medical practice and clinical trials, if it lives up to its promise (Nat. Rev. Drug Discov. 14, 735–737; 2015).

Otsuka's Abilify MyCite combines the drug developer's atypical antipsychotic aripiprazole with Proteus Digital Health's tracking device — a 1 mm ingestible chip that is activated when it comes into contact with stomach acid, sending a signal to a wearable band-aid sized patch, which is paired to a smartphone. The agency approved the product for schizophrenia, bipolar I disorder and depression.

The agency first approved aripiprazole for schizophrenia in 2002. It approved Proteus's device in 2012, but only as a stand-alone device that pharmacists could combine with active drugs using an 'over-encapsulating' capsule. Otsuka first submitted Abilify MyCite for approval in 2015, but the agency rejected it the following year. Otsuka resubmitted the product earlier this year.

The approval now provides “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,” says John Kane, psychiatrist at Northwell Health and investigator on Proteus-sponsored trials.

The FDA noted that the sponsors have not shown that the product improves treatment adherence.

Drug non-adherence is thought to be responsible for up to US$300 billion in avoidable health-care costs, including unnecessary hospitalizations, nursing home admissions and premature deaths. If Otsuka and Proteus can prove that their product does improve adherence, tracking technology will likely be paired with other drugs as well.

Drug developers are also interested in using tracking technologies in clinical trials, to ensure that trial participants take their drugs properly and to make it easier to interpret trial results. AiCure, another firm that is active in this space, uses video facial recognition to monitor adherence during clinical trials.