Here’s How Advanced Digestible ‘Digital Pills’ Are Becoming

Pfizer CEO Albert Bourla has touted a digestible “biological chip” in a tablet, but how soon will the tech actually come to mass market? Here’s an in-depth breakdown.

A clip of Pfizer CEO Albert Bourla has gone viral recently, showing the big pharma chief at a 2018 World Economic Forum (WEF) gathering touting a “biological chip” that can be swallowed in the form of a tablet—one, specifically, that, once it’s been ingested, “sends a signal that you took the tablet.”

But how soon should people expect to see bio-chip tablets in “doctors'” offices? Below is a look at three of the very real potential candidates, including the one Bourla references in the viral WEF clip immediately below. Which, as of this writing, is currently available on the market despite the fact its maker has gone bankrupt.

1. FDA-Approved Abilify MyCite

Although it’s been cut out from the clip, in a longer excerpt from the WEF gathering, Bourla prefaces his explanation of the biological chip by saying that the “FDA [has] approved the first electronic pill.” In 2017, the year prior to the WEF gathering, the FDA had approved (on November 13, 2017) Abilify MyCite (or “aripiprazole tablets with sensor”). The exact title of the approval was: “FDA approves pill with sensor that digitally tracks if patients have ingested their medication.”

“The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system,” the FDA’s press release notes. “Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.”

The FDA goes on to note the product is approved for the treatment of schizophrenia, manic and mixed episodes of bipolar disorder, as well as for use as an add-on treatment for depression in adults. The exact same approval profile as for regular Abilify, an antipsychotic that was approved for medical use in the United States in 2002.

In the video immediately above CBC news offers an overview of how Abilify MyCite works. As the news anchor describes, the digital pill has an inbuilt sensor and, when it comes into contact with “stomach fluids,” sends an electronic signal to a wearable patch that’s placed above a wearer’s left ribcage. The patch then transmits the information to an app so patients can track the ingestion of the medication on their phone. Patients can also permit their caregivers and physicians to access their data online.

Despite the fact Abilify MyCite was approved by the FDA in 2017, however, in September, 2020, after it failed to close a $100 million funding round in 2019, the electronic pill’s maker, Proteus Digital Health, went bankrupt. After being valued, at one point, at more than $1.5 billion.

“Proteus attempted to raise capital and get more financing this year but potential buyers were turned off because Proteus was burning through too much cash—to the tune of $2 million a month—and it wasn’t clear when the company would be profitable, according to an investment bank the company hired,” Fierce Healthcare wrote in a September 4, 2020 report.

Those knowledgeable on the matter with whom Fierce Healthcare spoke placed the blame for Proteus’ failure on the expense of their pills, as well as a lack of desire for the product.

Image: CBC News

“Just because you build something and build it well, it doesn’t mean there is a real need for your product in the healthcare ecosystem or it’s what the end-user wants,” Vasudev Bailey, a Ph.D. partner at Artis Ventures, who was not an investor in or advisor to Proteus, told Fierce Healthcare. “Pharma cares about non-compliance, but why should patients care?” Bailey added.

Despite the fact Proteus went bankrupt, however, Abilify MyCite is still available in the U.S. Indeed, there is a full-blown ad campaign for it targeting people with major depressive disorder. The digital pill is still available thanks to Otsuka Pharmaceutical, a Japanese pharmaceutical company headquartered in Tokyo. (Otsuka actually bought bankrupt Proteus for $15 million.)

Side effects listed on the Abilify MyCite website include: “unusual urges,” including gambling, binge eating, or shopping; strokes; increased risk of having suicidal thoughts; the lethal neurological syndrome “Neuroleptic malignant syndrome”; uncontrolled body movements, and high blood sugar.

2. etectRx’s FDA-cleared ID-Cap System

Abilify MyCite isn’t the only digital pill on the market. Private Florida-based “digital health” company etectRx offers a direct competitor in the form of its “ID-Cap System.” As MobileHeathNews notes “Similar to the system pioneered by etectRx’s high-profile competitor, Proteus Digital Health, the ID-Cap’s core is a standard capsule containing a sensor that transmits a message once it comes into contact with stomach fluid.”

MobileHealthNews notes the one big difference between Otsuka’s digital pill and etectRx’s is that the latter system—which is also approved by the FDA—has a receiving device that can be worn on a lanyard around the neck versus adhered to the skin.

“We view our technology as a tool to be used to provide a very valuable piece of information to the clinician or researcher,” etectRx President and CEO Harry Travis told MobileHealthNews. “We will work with our potential partners to ensure that this piece of data fits smoothly into the larger clinical data landscape,” Travis added.

The commercial below shows 31-year-old Court happy with his decision to take etectRx’s digital pills. “I felt confident that the digital pill was safe, I knew it was effective,” Court says in the video. “I didn’t have to worry about whether I could remember taking it and truly, it changed the way I approached my own health,” he adds.

At the time of his speaking with MobileHealthNews, Travis said that, with its FDA clearance, etectRx was turning its attention toward “a broad array of partnerships that could include, pharma manufacturers, digital health companies, health plans, clinical research organizations and specialty pharmacies.” He added that “Our long term commercialization plans will be to work with all of the above organizations to help them achieve their goals of better patient outcomes or more accurate research outcomes.”

3. MIT’s Ingestible Sensor

Although it—apparently—hasn’t gone through any clinical trials nor received FDA approval, engineers at MIT have developed an “ingestible sensor” that may one day be able to monitor peoples’ vital signs by measuring heart rate and breathing rate from within the gastrointestinal tract. MIT’s edible sensor not only has a different function than the ID-Cap System and Abilify MyCite, but also functions differently—relying on “very small microphones [that] are compatible with digestion.”

Inspired by existing ingestible devices that can measure body temperature, and others that take internal digestive-tract images, the researchers have designed “a sensor that [measures] heart and respiratory rate, as well as temperature, from inside the digestive tract,” MIT News reported on November 18, 2015. “This type of sensor could make it easier to assess trauma patients, monitor soldiers in battle, perform long-term evaluation of patients with chronic illnesses, or improve training for professional and amateur athletes,” the report added.

The whole edible sensor—outlined by its creators in the video immediately above—is approximately as large as a multivitamin pill and consists of a tiny microphone packaged in a silicone capsule—along with electronics that process sounds and then send radio signals to an external receiver.

As of 2015, MIT researchers had tested the digestible sensors inside the GI tracts of pigs. According to MIT News, the researchers found that the device could accurately pick up heart rate and respiratory rate, even if the digestive sounds of the pigs’ innards changed depending on what they were eating.

“We hope that one day we’re able to detect certain molecules or a pathogen and then deliver an antibiotic, for example,” Giovanni Traverso, a research affiliate at MIT’s Koch Institute for Integrative Cancer Research, a gastroenterologist at Massachusetts General Hospital, and one of the lead authors of a paper describing the device in the journal PLOS One, said in MIT’s press release. “This development provides the foundation for that kind of system down the line,” Traverso added.

Feature image: etectRx

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