(This article was updated at 5:30 p.m. ET.)
Proteus Health, a Redwood City, Calif.-based “smart-pill” startup, is asking the Food and Drug Administration to allow a sensor that detects whether a pill has been taken to be embedded in Abilify, a major drug used to treat schizophrenia.
The FDA has determined that the new drug application submitted by Proteus and Tokyo-based Otsuka Pharmaceutical Co., the maker of Abilify, is sufficiently complete and ready for a substantive review by regulators, the companies announced Wednesday.
Proteus aims to track medication adherence by combining its ingestible sensor with a wearable sensor patch and a software application. When a medication embedded with the sensor reaches the stomach, it sends a signal to the patient's patch, which records and time-stamps the information along with other metrics such as rest and activity patterns. Abilify would be the first FDA-approved medication that would carry an ingestible sensor, although patients would be able to choose a non-sensor version as well.
The information from the patch is recorded and relayed to patients on their mobile phone or other Bluetooth-enabled device, and can be sent to their physician or caregivers with their consent. The transmitter in the device sends a unique signal corresponding to the specific pill and powered by a very low-voltage charge created when trace amounts of copper and magnesium come into contact with bodily fluids.
The sensor has been previously approved for placement in a placebo pill to be taken along with a patient's assigned medication.
Proteus and Otsuka are hoping to solve the widespread issue of medication non-adherence among chronic disease sufferers, especially those with mental illness. The World Health Organization estimates that roughly 50% of patients with chronic diseases don't take their medications as prescribed, and it's not unusual for patients with chronic mental disorders such as schizophrenia to stop taking their medications, or to not take them as prescribed, which can lead to a relapse or recurrence of symptoms.
The FDA suggested that the need for an ingestible sensor was greatest among mental-health patients when Proteus began talking with the agency several years ago, said Dr. George Savage, Proteus' co-founder and chief medical officer. Proteus hopes to give patients feedback on their adherence so they can improve their health and avoid adverse events, he said.
“Having a closed-loop system where you figure out what you're doing (right or wrong), in the context of drug therapy—we believe that kind of closed-loop feedback system could be helpful,” Savage said.
Medication adherence problems are responsible for $100 billion to $300 billion in avoidable healthcare costs because poor adherence escalates the need for treatment and adds other indirect costs, according a 2014 article in the journal Risk Management and Healthcare Policy. Those figures represent 3% to 10% of all U.S. healthcare costs.
“Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression,” said Dr. William Carson, president and CEO of Otsuka Pharmaceutical Development & Commercialization. “We believe this new digital medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population.”
Savage said he expects a response from the FDA by late April. The agency doesn't comment on drug applications that may be under review, a spokeswoman said.