The U.S. Food and Drug Administration has approved a digital pill for the first time today, paving the way for other forms of connected medicine that could shape the future of healthcare.

The newly approved pill is called Abilify MyCite, and it’s designed to sense when patients have taken their dose of Abilify, an antipsychotic that is commonly used to treat mental disorders such as schizophrenia and bipolar disorder.

The pill, which was designed by Silicon Valley health startup Proteus Digital Health, contains an ingestible sensor that detects the release of the drug and communicates that information to a patch worn by the patient. The patch then shares that data with a smartphone app, which can be seen by doctors and up to four other people, including the patient’s family members.

The idea behind Abilify MyCite is help doctors ensure that their patients are taking their medication when they should be, which is a problem for many people, especially mental health patients. It also makes it easier for patients to know when they have already taken their medicine, which Proteus noted in a statement could save the lives of elderly patients who suffer from dementia. According to Proteus, elderly patients taking antipsychotics for dementia are at a much higher risk of death compared to similar patients who were prescribed placebos.

Proteus, along with Abilify creator Otsuka Pharmaceutical Co. Ltd., believes that its new pill is only one example of the many ways digital medicine can improve healthcare.

“The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness,” said Andrew Thompson, president and chief executive of Proteus Digital Health. “Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”

Abilify MyCite may raise some privacy concerns, but patients must also agree to the pill and sign a release prior to taking it. Patients can also opt out of the program at any time.

Photo: Proteus Digital Health