It’s a pill. It’s a device. It’s both. FDA Approves the first Digital Drug Therapy

Adherence to prescription drug therapies is a big problem, not only for patients and drug developers, but also for payers who cover the costs of such medications and then pay to treat problems the drugs were meant to prevent. About 10 years ago, the New England Journal of Medicine estimated that up to two-thirds of medication-related hospital admissions in the United States were due to noncompliance, at a cost of about $100 billion a year. Non-compliance is an especially serious problem among patients with mental illnesses, where patients too often stop taking their medications as they begin to feel better.

 

Abilify MyCite

Abilify MyCite. Photo: Proteus Digital Health

On November 13, 2017, the U.S. Food and Drug Administration approved the first dose-tracking drug aimed at aiding patient adherence with drug therapy. The new product is a digital version of Otsuka Pharmaceuticals’ Abilify (aripiprazole), used for the treatment of schizophrenia, bipolar disorder, and as an add-on therapy for depression. Named Abilify MyCite, it consists of a pill fitted with a tiny sensor, the size of a grain of sand, which triggers a signal when the pill encounters stomach acid. The signal is picked up by a patch worn by the patient that transmits the information to a smart phone app. The patient can then choose to transmit the information to their doctor or designate another person to be able to track their dosing. The patch and app also enables patients to track and record their mood, sleep, and activity level.

 

Abilify is not a new drug—in fact, a low-cost generic version is available as well as an injectable long-lasting branded version—and Otsuka plans to begin with a limited launch of the digital version, to learn from the initial patient experience. Abilify MyCite is perhaps a bigger achievement for Proteus Digital Health, which has been working on the sensor employed in the new product for years. Proteus has additional digital pill products in the works, including sensor-embedded versions of the generic blood pressure pill Lisinopril and the diabetes drug metformin. Additionally, the sensor was approved by the FDA in 2016 for use on its own; health system pharmacies in nine states can be commissioned to place the tiny sensors in capsules with other medications—for example, to improve drug adherence in patients with uncontrolled hypertension.

 
There are certainly privacy concerns about pills that track patient behaviors, as well as worries that technology of this sort could be an undesirable step towards punishing patients who don’t comply. Furthermore, there are questions about how successful an approach like this will be in gaining the acceptance of mental health patients who may already be very suspicious of people and technology monitoring their behaviors.

 
However, the FDA is anticipating more approval requests for digital pills. It is reportedly planning to hire more staff with a deep understanding of software development in relationship to medical devices, and to engage with entrepreneurs to develop new guidelines for such products.