Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Pills Have Gone Digital
Posted on November 24th, 2017 by Betsy Davis in Pharma R&D
Paranoiacs and conspiracy theorists beware – the digital pill is here. The U.S. Food and Drug Administration announced on November 13 that it had approved Abilify MyCite (aripiprazole tablets with sensors), the first drug in America to have a digital ingestion tracking system. By the next day, Abilify’s maker—Otsuka Pharmaceutical Co.—was seeing its stock rise.
Abilify, or aripiprazole, probably already sounds familiar to you. That’s because the drug, an antipsychotic, was first approved in 2002 to treat schizophrenia. In a feature on the drug, Tim Newman of Medical News Today, explains that “Aripiprazole is used predominantly for the treatment of schizophrenia and bipolar disorder but can also be used as an add-on treatment for major depressive disorder, tic disorders, obsessive-compulsive disorders and irritability associated with autism.”
This new version, Abilify MyCite, developed by Otsuka and Proteus Digital Health, seeks to solve a common problem when it comes to medication: nonadherence. In the paper Medication adherence in schizophrenia, published in the World Journal of Psychiatry, researchers note that estimated non-adherence rates are about 50%. Failure to take medication can result in further hospitalization, risk of suicide, job loss, violence, arrest, psychiatric emergencies and more. “The annual costs of schizophrenia amount to ￡400 million in the United Kingdom and over $10 billion in the United States,” say the paper’s authors, attributing 40% of costs associated with schizophrenia treatment to non-adherence.
Abilify MyCite deals with this problem by embedding in the pill an ingestible sensor that sends a message to a patch that the patient wears, and the patch in turn transmits the information to a smartphone app. “Coming into contact with fluids in the stomach, the sensor is activated and communicates this to the MyCite Patch. Then, the sensor is digested and eliminated from the body,” explains Susan Scutti, reporting for CNN. “Meanwhile, the patch detects and records the date and time when the tablet was detected in the stomach in addition to physiological data, such as the patient’s activity level.”
In the New York Times, Pam Belluck notes that other companies are developing similar technologies, including ones that can even confirm if the patient has put the pill on their tongue and swallowed it. “Not all will need regulatory clearance, and some are already being used or tested in patients with heart problems, stroke, HIV, diabetes and other conditions.” Belluck also points out that this kind of technology could be used to ensure that clinical trial participants are adhering to the correct guidelines, and that it could even be helpful in monitoring how much opioid medication post-surgical patients are taking.
By bringing the act of taking medication—something that even the most detail-oriented people can easily forget—into the digital age, Abilify MyCite has the power to improve adherence by making it easier to monitor. But, even better, patients can give their caretakers or doctors access to the information, so that people they trust can help them stay regular with their medication. That said, CBS News highlights a potential hurdle that Otsuka and Proteus may be facing, saying “The pill has not yet been shown to actually improve patients’ medication compliance, a feature insurers are likely to insist on before paying for the pill.” They also emphasize that, of course, it is a patient’s choice whether or not to share their Abilify MyCite information with others, and some users may not be willing to forgo their privacy for the extra monitoring support.
There is also the “Big Brother” factor, which will deter people who don’t like the idea of having any kind of sensor inside their body. Though the Abilify MyCite sensor is said to be as small as a grain of sand, made from ingredients used in food products, and will be destroyed in the patient’s stomach, there is bound to be reticence among some. However, if we have learned one thing from the digital age—in which we allow our phones to track our movements and empower companies like Google and Amazon to know everything about us—it’s that humans are willing to surrender privacy for ease. So expect more digital drugs to be vying for a place in your medicine cabinet in the near future.
All opinions shared in this post are the author’s own.
R&D Solutions for Pharma & Life SciencesWe're happy to discuss your needs and show you how Elsevier's Solution can help.
Senior Strategic Marketing Manager
- Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue
- FDA Announces Plans to Improve Approvals Process for Medical Devices
- Emulating start-up success with purpose-built data tools
- Finding Answers Where You Least Expect Them
- Machine Learning Could Make Drug Discovery Faster, Cheaper, Better