Proteus Digital Health Inc. and Otsuka Pharmaceutical Co. Ltd. have received FDA approval to market what they call 'digital pill' technology to treat mental health disorders. Abilify Mycite is a drug-device combination product that consists of Tokyo-based Otsuka's oral aripiprazole tablets, embedded with Redwood City, Calif.-based Proteus' ingestible event marker sensor.
Otsuka's Abilify is used to treat depression, bipolar disorder and schizophrenia.
The private companies said the sensor is about the size of a grain of sand and is activated by stomach fluids, sending a signal to a patch worn on the patient's torso and transmitting the information to a smartphone application. The system records medication ingestion and communicates it to the patient and health care provider. In addition, it can collect data on activity level, as well as self-reported rest and mood which, with patient consent, can be shared with the health care provider and selected members of the family and care team.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers."
However, the FDA noted there hasn't been an established association between using the digital pill platform and increased patient adherence to drug regimens.
Already the cost of patients not taking their medication correctly leads to costs of $100 billion worldwide each year, according to a report from the IMS Institute for Healthcare Informatics.
Tough pill to swallow
Abilify was first approved by the FDA in 2002 to treat schizophrenia. The drug is sold by New York-based Bristol-Myers Squibb Co. in the U.S.
It recently went off patent, giving Otsuka competition from Teva Pharmaceutical Industries Ltd. In 2015, Otsuka lost a lawsuit challenging the FDA for the agency's approval of generic versions of Abilify.
The FDA had initially rejected the companies' submission of the drug-device combo a little more than a year ago. At the time, both companies said the agency requested additional information in the new drug application, including additional human factors testing to ensure the device could be used safely and effectively and data about the device's performance under the conditions in which it is likely to be used. (See BioWorld Today, April 28, 2017.)
Both companies resubmitted an application for Abilify Mycite in May.
Proteus received 510(k) clearance for its ingestible sensor in July 2012. The company picked up a CE mark in 2010. The Proteus Patch records time of ingestion along with steps, rest and heart rate, and communicates to a mobile application via Bluetooth.
Bringing in funding, partnerships
The approval of Abilify Mycite paves the way for Proteus' other partnerships to blossom.
In early 2016, Proteus received a $40 million investment from Harbin, China-based Gloria Pharmaceuticals Co. Ltd. in an effort to take part in the firm's series H funding round. Under the terms of that deal, Gloria was able to establish a joint venture with Proteus that would have a focus on chronic diseases such as hypertension, diabetes and mental illness.
Ideally, Gloria and Proteus' pairing could lead to a digital pill focusing on another disease state.
Proteus has also been working with Basel, Switzerland-based Novartis AG since 2010 to develop sensor-based products for organ transplantation, according to Cortellis Competitive Intelligence. As part of the deal, Novartis invested about $24 million in up-front cash and equity.
In 2009, Novartis enlisted Proteus for a 20-patient study to track patients' compliance with a blood pressure drug regimen.
Proteus has captured the attention of other investors, which include Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic plc, Oracle and On Semiconductor.
Those investors have contributed more than $300 million in funding since Proteus became a company in 2001. In July 2014, the company reported completion of a second closing of its series G financing, raising more than $172 million.
Removing patient control?
The Abilify Mycite approval has raised some questions about the device and possible intrusiveness of the technology. Critics of the technology have said it could severely hamper a patient's control in taking medication. Others have said it could possibly impinge on privacy.
The companies said patients have to agree that their physicians can see the data and can choose whether or not to share information with caregivers, such as family members.
Omada Health Inc. Chief Privacy and Regulatory Officer Lucia Savage said it will take discussions between the patient and the physician to alleviate some of those concerns.
Savage, the former chief privacy officer at the office of the National Coordinator for Health IT, joined San Francisco-based Omada Health in February. Omada is a digital behavioral medicine company.
"If an individual is interested in taking Abilify Mycite because they think it's going to help them with their compliance, that should be a dialogue they're having together with their physician," Savage, told BioWorld. "The prescription should be clear about what the signal [coming from Abilify Mycite] does and doesn't do and how secure and not secure it is and how private or not private it is. Those things should all be happening in the conversation with the patient."
While Abilify Mycite changes the mode of delivery for patient adherence, the concept has always been around, said Savage, who is a veteran in the health care industry.
She said about 15 years ago, insurers would analyze the claims data in health plans to develop algorithms to figure out if the physicians were billing for the preventive services they were supposed to be supplying.
"One of the first instances of this was measuring rates of breast cancer screening compliance," Savage said. "The algorithm was derived from looking at the number of women clinically eligible for a mammogram and counting how many did have the mammogram compared to how many should have had the screening."
Savage said patients would then receive letters reminding them to get a screening.
"For every person who called the privacy office [of insurers] upset that they got this letter, we also got a call from a person who said, 'Wow, that reminder saved my life,'" Savage said. "Analyzing the techniques to help the individuals get the right care at the right time has been going on for a really long time. [Abilify, Mycite] is a very sophisticated biochemical, digital signaling way of doing the same thing if you think about it."