U.S. authorities approved the world’s first digital drug, an antipsychotic pill that signals smartphones once it reaches the gut so doctors can track whether patients are taking their medication.
Tuesday’s green light from the Food and Drug Administration means Japan’s Otsuka Pharmaceutical Co. can implant a tiny chip containing minerals like silicon, magnesium and copper inside tablets of Abilify, which is used to treat schizophrenia, bipolar disorder and other mental illnesses.
Digital drugs may also solve a couple of problems facing pharmaceutical companies and insurers: lower drug sales because of missed doses and higher medical costs treating patients whose conditions worsen.
To succeed, the Japanese drugmaker must convince doctors that digitized Abilify significantly improves patients’ compliance compared with the original pill and cheaper copies that are now available.
Otsuka’s digital pill is competing against its own alternative form of Abilify: a long-acting injection that reduces the risk of patients’ missing doses because it is supervised by a doctor.
Researchers at Harvard University-affiliated Brigham and Women’s Hospital in Boston and the Massachusetts Institute of Technology last month published test results from an ingestible device that can sense how frequently a person is eating.