Why Pharma Wants to Put Sensors in This Blockbuster Drug

 In U.S.
Update: On November 13, 2017, the FDA approved the Abilify “digital pill,” the first time the agency has accepted a medication embedded with a sensor.

Getting people to take their pills is hard, especially with mental illnesses like schizophrenia and bipolar disorder. But to use the language of techno-optimism: “There’s an app for that!”

No, really. This month, the Food and Drug Administration accepted an application to evaluate a new drug-sensor-app system that tracks when a pill’s been taken. The app comes connected to a Band Aid-like sensor, worn on the body, that knows when a tiny chip hidden inside a pill is swallowed—so if patients aren’t keeping up with their meds, the program can alert their doctors.

The drug here is Abilify, a popular antipsychotic from the pharmaceutical giant Otsuka, and the sensor and the app come from Proteus Digital Health, a California-based health technology company. The FDA has already approved the drug and the sensor system separately—now, they’ll be evaluated together under a whole new category of “digital medicines.” If approved, the ingestible sensor can actually be used in the pill.

Medication adherence—to use the medical jargon—is especially a problem among patients with serious mental illnesses. In one study, 74 percent of patients with schizophrenia stopped taking their prescribed drug within 18 months. “I think the adherence issue is particularly relevant to serious mental illness,” says Otsuka’s chief strategic officer Bob McQuade. “We believe this is the right digital medicine at the right time and for the right indication.”

Because this combo of pill and tech is so new, the companies had to work with the FDA to even figure out what kind data to submit to get approval. That the agency is willing to try something new points to the potential of Proteus’s chip and sensor, which can work in any type of pill.

But submitting the FDA application with an antipsychotic raises a few extra eyebrows. When it comes to adherence, “this is as good as any high-tech method today,” says Eric Topol, who holds an endowed chair in innovative medicine at Scripps Translational Science Institute. “The question is, how well does the technology meet up with this specific need?”

Some context might help.

A Blockbuster Drug Goes Generic

Abilify, used to treat schizophrenia, bipolar disorder, and depression, was the number one selling drug in the US in 2013. But in 2015, things came crashing down. Otsuka’s patent for Abilify expired, and the company’s last-ditch attempt to prolong the patent in a convoluted lawsuit with the FDA failed. The FDA approved generic versions of Abilify, also called aripiprazole, in April.

Pharmaceutical companies have a history of reformulating off-patent drugs, changing them to an extended release pill or a liquid version to get a new patent. McQuade, though, contends that the curious timing of this new version of Abilify with a built-in sensor has nothing to do with its patent expiring and everything to do with Abilify being a popular and relatively safe drug that would be easy to get through the FDA’s brand new approval process.

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