For Andrew Thompson, cofounder and CEO of Proteus Digital Health, this week in which the U.S. Food and Drug Administration granted approval for the first ingestible sensor-embedded drug Abilify Mycite is a momentous time. It marks a significant advancement for people with serious mental health disorders to work with their physicians to better manage their condition. But it also paves the way for other drug-sensor combinations that could help patients, parents, and caregivers monitor medication adherence and effect.
Longterm, the approval could also have a transformative effect on clinical trials for drug development.
Thompson noted that Abilify Mycite, which Otsuka Pharmaceutical expects to hit the market early next year, will create datasets that enable new ways for physicians and care teams to engage with patients.
“That is a powerful opportunity that answers some of the most basic questions in healthcare: ‘Did you take the medications and did they work?’”
One of the challenges for people with schizophrenia, bipolar disorders, and severe depression, the kinds of conditions Abilify is designed to treat, is that missing their medication can lead to serious consequences. A medication that’s so closely aligned with a monitoring tool could make the job of adherence easier and improve the rapport between patients and physicians since the platform gives them access to similar data.
Of course, there is also the potential for this monitoring tool to put patients on the defensive or even undermine their relationship with caregivers and their physician. But it’s not being presented as a solution for everyone with these conditions.
Dr. John Kane with Behavioral Health Services at Northwell Health said in a Proteus news release that prior to Abilify Mycite’s approval, pharmacologic therapy for serious mental illness had been missing a systematic approach to objectively track and signal that a patient has taken their drug.
Despite the approval, there are even more questions about the direction Proteus will take now and how the healthcare industry responds.
“How will Abilify Mycite and other products like it get paid for and how will they be valued? This going to be a journey that we are only just beginning,” Thomspon said.
Looking back on the snags the Otsuka and Proteus hit on the path towards approval, the regulator focused on Otsuka’s software and the human factor — would people with serious mental health disorders be able to use this technology effectively? For its part, an Otsuka spokeswoman noted in an email that in response to a Complete Response Letter last year, the company reduced the error rate of people using Abilify Mycite from 12.1 percent to 1.5 percent and simplified the user experience.
Although Thompson couldn’t say who would be the next pharma partner for Proteus, he noted that indications could span from people taking retrovirals to treat HIV, ADHD in children and seniors taking medication for a cardiovascular disease. In each situation, parents and caregivers, in particular, would want to confirm patients had taken their medication.
“This is an excellent example of a drug where adherence is necessary to stay well and failure to use these medicines results in [serious] consequences really quickly.”
Another area where the milestone of a sensor embedded in a pill can have a transformative effect is the drug research and development. But the challenge this presents is defining what adherence looks like and all that questions that accompany that deceptively complex question.
“Our solution is to start with drugs that have been approved already that can extend the medicinal label…Once that happens, this is one of the most significant opportunities in history to enhance the regulatory science.”
Source: Proteus Digital Health
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