Digital pills: hard to swallow offerings or absolutely necessary?

Many people worldwide live with at least two chronic conditions, receiving long-term treatment. Their disease control depends on treatment adherence.

However, half of them do not take their medications as prescribed. Poor treatment adherence leads to life-threatening events and increasing costs for the healthcare system.

The digital pill promises to address the unmet need of poor patient adherence.

Otsuka Pharmaceutical Co and Proteus Digital Health partnered to develop the first digital pill but later ditched the agreement.

Digital health innovations enhance patients’ quality of life and ensure their safety through personalized medicine.

The digital pill, which promised a solution other technologies failed to deliver, tracked whether or not the patients had swallowed their pills and provided reliable information to healthcare providers.

Otsuka Pharmaceutical Co and Proteus Digital Health developed the first digital pill, and FDA approved it in 2017.

The pill included a digital ingestion tracking system. The digital pill’s sensor, made from silicone, magnesium, and copper, was activated by acid in the stomach and generated an electrical signal picked up by a patch worn on the patient’s ribcage. The patch through Bluetooth sent the information to a mobile app that saved the date and time the patient took the pill.

It was launched under the commercial name Abilify MyCite and contained aripiprazole, a drug used in treating psychiatric conditions.

This tracking was revolutionary for patients suffering from psychiatric conditions like depression and schizophrenia; in their case, missed doses have serious consequences.

While Proteus raised over $500 million in venture capital and was valued at $1.5 billion in 2019, it went bankrupt in June 2020. The pressure to hit milestones quickly and the abrupt termination of its partnership with Otsuka made it difficult to raise more capital.

Besides this, the low monthly cost of generic aripiprazole drug (less than $20 per month) compared to the Abilify Mycite reported price of $1,650 per month imposed financial restrictions on individuals and insurance companies.

EtectRx, Infarmate, Medimetrics and Medtronics to join the digital pill game.

Failure of Proteus reflects a company failure, not a technology one. The digital pill can still benefit specific patient populations, which is why there has been further interest in the field.

EtectRx developed a digital pill that uses an ID-Cap system, and FDA approved it in 2019.

It uses a technology that transmits a very low-power digital message from within the patient’s stomach each time they swallow an ID capsule. The patient wears a reader that detects the message sent from ingested ID-Tags and forwards it to the patient’s smartphone and clinician’s dashboard.

Spain-based Infarmate is developing a similar solution, SIGUEMED, for elderly patients with chronic diseases, to encourage them to take medication correctly. This cost-effective solution comes with a trackable blister pack, alerting caregivers when patients take a pill.

Medimetrics, a pioneer in electronic, oral drug delivery, has created Intellicap technology. IntelliCap system is based on a swallowed electronic capsule that controls drug release and allows the delivery of precise amounts of medicine to a targeted part of the patient’s body. It incorporates GI track navigation technology in the body and delivers laboratory measurements for physical parameters.

There are also smart pills for capsule endoscopies (gastrointestinal diagnosis and therapy). Medtronic has PillCam COLON Capsule, which replaces invasive colon exams. And CapsoVision has raised around $33 million over the years to develop its Capsule colonoscopy platform on the CapsoCam Plus, a smart pill providing a full 360º panoramic lateral view of wherever it is traveling in high resolution. CapsoVision is approved for adults in the US and Europe and claims to be “currently working in 70+ countries through strong distribution partners”.

The digital pill raises privacy and cybersecurity concerns.

At the same time, privacy issues arose around the adoption of the digital pill.

A sensor in the body tracking 24×7 feels quite intrusive, especially for schizophrenia patients.

Apart from that, the risk of third parties hacking and misusing medical information is another challenge to be addressed.

How will companies overcome ethical and social concerns? Will the digital pill become the new normal?

Concerns around privacy, cost, and management over effectiveness made Proteus a pill hard to swallow.

Despite this, we see potential in this technology. Tracking the use of medication informs doctors about any missed doses, prevents dependency in cases of opioid medication during post-surgery recovery, and results in fewer and shorter hospitalizations. Gastrointestinal diagnosis and therapy become easier with capsule endoscopy. And Infarmate and EtectRx products meet patients’ needs for more control over monitoring, calm their concerns about privacy issues and foster trust between patients and caregivers over time.

To establish this trust, the digital pill companies must comply with HIPPA or other patient privacy laws that ensure technology works for the benefit of the patients rather than against them.

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Sources:

https://medcitynews.com/2020/06/proteus-files-for-bankruptcy-where-did-it-falter/

https://medcitynews.com/2017/11/proteus-digital-health-ceo-on-fda-approval/

https://www.forbes.com/sites/angelauyeung/2019/04/01/take-your-medicine-this-15-billion-health-startups-smart-pills-keep-patients-from-forgetting/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3934668/

https://cordis.europa.eu/article/id/418365-pill-tracking-device-promises-targeted-personalised-care

https://medcitynews.com/2019/12/new-smart-pill-maker-gains-fda-approval/

https://www.statnews.com/2020/01/14/proteus-otsuka-key-pharma-partnership-unravels/

https://www.fiercebiotech.com/medtech/digital-pill-developer-proteus-files-for-bankruptcy

https://innovarum.es/en/project-portfolio/siguemed-phase-1/